Clinical trial • Phase III • Immunology|Nephrology|Rare Disease

FELZARTAMAB for IgA nephropathy

Phase III trial of FELZARTAMAB for IgA nephropathy.

Overview

Trial Therapeutic Area
Immunology|Nephrology|Rare Disease
Trial Disease
IgA nephropathy
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
30-05-2025
First CTIS Authorization Date
23-09-2025

Trial design

Randomised, placebo (0.9% saline) administered as the comparator; given per study schedule (patients receive felzartamab or placebo at weeks 0, 1, 2, 3, 4, 8, 12, 16, and 20).-controlled Phase III trial in Greece, Portugal, Belgium and others.

Randomised
Yes
Comparator
Placebo (0.9% Saline) administered as the comparator; given per study schedule (patients receive felzartamab or placebo at weeks 0, 1, 2, 3, 4, 8, 12, 16, and 20).
Target Sample Size
484
Trial Duration For Participant
728

Eligibility

Recruits 484 Vulnerable population flag selected (isVulnerablePopulationSelected=true). Informed consent is obtained via Main ICF documents; additional consent forms are provided where relevant (e.g., PGx ICF, Pregnant-Partner-and-Pregnant-Participant-ICF, Future Scientific Research / Optional Genetic ICF). eConsent options are available (eConsent documents present). Consent materials and study information are provided in multiple country/language-specific ICFs and recruitment materials (examples: English, Portuguese, Polish, Czech, Dutch, French, Bulgarian, Italian, Spanish, German, Greek, Croatian). No paediatric assent procedures are described (study population is adults)..

Vulnerable Population
Vulnerable population flag selected (isVulnerablePopulationSelected=true). Informed consent is obtained via Main ICF documents; additional consent forms are provided where relevant (e.g., PGx ICF, Pregnant-Partner-and-Pregnant-Participant-ICF, Future Scientific Research / Optional Genetic ICF). eConsent options are available (eConsent documents present). Consent materials and study information are provided in multiple country/language-specific ICFs and recruitment materials (examples: English, Portuguese, Polish, Czech, Dutch, French, Bulgarian, Italian, Spanish, German, Greek, Croatian). No paediatric assent procedures are described (study population is adults).

Inclusion criteria

  • {"criterion_text":"- Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, biopsy confirmation of IgAN diagnosis must be done within the past 24 months prior to signing the ICF.\n- An eGFR ≥ 30 mL/min/1.73m^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and < 30 mL/min/1.73m^2 is acceptable for the cohorts 3 and 4.\n- Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening, or intolerant of ACEI or ARB. If intolerant, this must be discussed with the Medical Monitor prior to randomization. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is), endothelin receptor antagonists (ERAs) approved for the treatment of IgAN, dual endothelin angiotensin receptor antagonists (DEARAs) approved for the treatment of IgAN, and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using sparsentan will not be permitted to use simultaneous ACEI or ARB medication.\n- Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection."}

Exclusion criteria

  • {"criterion_text":"- Secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.\n- Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, MMF or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (> 7.5 mg/d prednisone/prednisolone equivalent) within 4 months (or 12 months for rituximab) prior to Screening.\n- Note: Other protocol defined Inlcusion/Exclusion criteria may apply\n- Participants currently treated with oral budesonide. Patients who have stopped this therapy ≥ 4 months prior to Screening may be eligible.\n- Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or IV anti- infectives (antibacterials, antivirals, or antifungals). Participants with a history of opportunistic infections are excluded.\n- History of rapidly progressive variant of IgAN, defined as eGFR loss by > 50% per 3 months and not explained by changes in RAS blockade or other factors.\n- Nephrotic syndrome presumed to be due to minimal change disease (MCD) variant\n- Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.\n- Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) > 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).\n- Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, Human Immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.\n- Hypogammaglobulinemia: Serum Immunoglobin G (IgG) < 6.0 gram per litre (g/L), at Screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)","definition_or_measurement_approach":"Measured by the Urine Protein:Creatinine Ratio (UPCR) — percent change from baseline."}

Secondary endpoints

  • {"endpoint_text":"- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Values Calculated Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation","definition_or_measurement_approach":"Change from baseline in eGFR calculated using the CKD-EPI creatinine equation."}
  • {"endpoint_text":"- Percentage of participants who progressed to Kidney Malfunction. The percentage of participants progressing to kidney malfunction will be reported based on one of the following, 1. ≥ 40% reduction in eGFR sustained for ≥ 30 days; 2. eGFR < 15 mL/min/1.73m2 for ≥ 30 days; 3. Undergoing dialysis for ≥ 30 days; 4. Undergoing kidney transplantation; 5. Died from kidney failure","definition_or_measurement_approach":"Composite kidney-malfunction endpoint defined as any of: ≥40% sustained eGFR reduction for ≥30 days; eGFR <15 mL/min/1.73m2 for ≥30 days; dialysis ≥30 days; kidney transplantation; death from kidney failure."}
  • {"endpoint_text":"- Percentage of participants requiring rescue therapy","definition_or_measurement_approach":"Proportion of participants who receive protocol-defined rescue therapy."}
  • {"endpoint_text":"- Felzartamab serum concentrations over time","definition_or_measurement_approach":"Pharmacokinetic measurement: serum felzartamab concentrations measured at specified timepoints."}
  • {"endpoint_text":"- Number of patients with anti-drug antibodies (ADAs) against felzartamab","definition_or_measurement_approach":"Immunogenicity assessment: number of participants positive for anti-drug antibodies against felzartamab."}
  • {"endpoint_text":"- Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)","definition_or_measurement_approach":"Safety assessment: incidence (%) of TEAEs and TESAEs as reported per protocol definitions."}
  • {"endpoint_text":"- Number of patients with Clinically Significant Change From Baseline in Vital Signs Abnormalities","definition_or_measurement_approach":"Count of participants with clinically significant changes in vital signs compared to baseline."}
  • {"endpoint_text":"- Number of Participants With Clinically Significant Change From Baseline in Physical Examination Abnormalities","definition_or_measurement_approach":"Count of participants with clinically significant physical exam abnormalities vs baseline."}
  • {"endpoint_text":"- Percentage of participants Achieving complete response (CR) CR is defined as UPCR value (based on 24-hour urine collection) of <0.5 gram per gram (g/g), a reduction in UPCR of ≥50%, and a stable eGFR (decrease from baseline in eGFR of ≤25%)","definition_or_measurement_approach":"Complete response (CR) defined as UPCR <0.5 g/g (24-hour collection), ≥50% reduction in UPCR, and stable eGFR (≤25% decrease from baseline)."}
  • {"endpoint_text":"- Change in Baseline in EGFR Values Calculated Using the CKD-EPI Creatinine Equation","definition_or_measurement_approach":"Change from baseline in eGFR calculated using the CKD-EPI creatinine equation."}
  • {"endpoint_text":"- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities","definition_or_measurement_approach":"Count of participants with clinically significant laboratory value changes compared to baseline."}
  • {"endpoint_text":"- Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Abnormalities","definition_or_measurement_approach":"Count of participants with clinically significant ECG abnormalities vs baseline."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
484
Recruitment Window Months
46
Consent Approach
Informed consent obtained from adult participants via Main ICF (country/language-specific). Additional optional/secondary consents include PGx ICF, Future Scientific Research / Optional Genetic ICF, Pregnant-Partner-and-Pregnant-Participant ICF; eConsent procedures are available (eConsent documents present). Scout Clinical telephone pre-ICF/telephone data consent used for pre-screening in some countries. Consent materials are provided in multiple languages (examples from document list: English, Portuguese, Polish, Czech, Dutch, French, Bulgarian, Italian, Spanish, German, Greek, Croatian).

Methods

  • Site-based recruitment via participating hospitals/clinics (nephrology departments).
  • Healthcare professional engagement: doctor letters and site referral materials for clinicians.
  • Printed materials at sites: patient posters, appointment cards, recruitment brochures, welcome guides, thank-you cards.
  • Patient-targeted digital channels: patient recruitment websites and patient portals specific to country/language.
  • Pre-screening telephone contact and Scout Clinical telephone pre-ICF processes (Scout Clinical pre-ICF telephone data consent described).
  • Use of country-specific recruitment packs and localised materials (country-specific K1/K2 recruitment documents referenced for Belgium, Portugal, Czechia, Croatia, Poland, Greece, France, Germany, Spain, Italy, Bulgaria, etc.).
  • Central guidance/memos for recruitment vendors (Advarra memos present) and site recruitment materials managed by third parties.

Geography

Total Number Of Sites
87
Total Number Of Participants
201

Greece

Earliest CTIS Part Ii Submission Date
25-06-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
287
Number Of Sites
11
Number Of Participants
18

Sites

Site Name
University General Hospital Of Ioannina
Department Name
Nephrology Department
Principal Investigator Name
Evangelia Ntounousi
Principal Investigator Email
evangeldou@gmail.com
Contact Person Name
Evangelia Ntounousi
Contact Person Email
evangeldou@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Department of Nephrology
Principal Investigator Name
Konstantinos Stylianou
Principal Investigator Email
kstylianu@gmail.com
Contact Person Name
Konstantinos Stylianou
Contact Person Email
kstylianu@gmail.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
Nephrology Unit of the 2nd Propaedeutic Clinic of Internal Medicine NKUA
Principal Investigator Name
Sofia Lionaki
Principal Investigator Email
sofia.lionaki@gmail.com
Contact Person Name
Sofia Lionaki
Contact Person Email
sofia.lionaki@gmail.com
Site Name
General Hospital Of Arta
Department Name
Nephrology Department
Principal Investigator Name
Chariklia Gouva
Principal Investigator Email
gouvachara@gmail.com
Contact Person Name
Chariklia Gouva
Contact Person Email
gouvachara@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Department of Nephrology and Kidney Transplantation
Principal Investigator Name
Evangelos Papachristou
Principal Investigator Email
epapachr@upatras.gr
Contact Person Name
Evangelos Papachristou
Contact Person Email
epapachr@upatras.gr
Site Name
Hippokration Hospital
Department Name
Nephrology Department
Principal Investigator Name
Dimitrios Petras
Principal Investigator Email
petrasdim@hotmail.com
Contact Person Name
Dimitrios Petras
Contact Person Email
petrasdim@hotmail.com
Site Name
General Hospital Venizeleio
Department Name
Nephrology Department
Principal Investigator Name
Dimitrios Xydakis
Principal Investigator Email
dxydakis@gmail.com
Contact Person Name
Dimitrios Xydakis
Contact Person Email
dxydakis@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Nephrology Department
Principal Investigator Name
Gerasimos Bamichas
Principal Investigator Email
gbamihas@gmail.com
Contact Person Name
Gerasimos Bamichas
Contact Person Email
gbamihas@gmail.com
Site Name
General Hospital Of Athens G Gennimatas
Department Name
Nephrology Department
Principal Investigator Name
Georgios Moustakas
Principal Investigator Email
georgemoustakas@gmail.com
Contact Person Name
Georgios Moustakas
Contact Person Email
georgemoustakas@gmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
Department of Nephrology and Renal Transplantation
Principal Investigator Name
Smaragdi Marinaki
Principal Investigator Email
smaragdimarinaki@yahoo.com
Contact Person Name
Smaragdi Marinaki
Contact Person Email
smaragdimarinaki@yahoo.com
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
2 nd Department of Nephrology
Principal Investigator Name
Vassilios Liakopoulos
Principal Investigator Email
liakopul@otenet.gr
Contact Person Name
Vassilios Liakopoulos
Contact Person Email
liakopul@otenet.gr

Portugal

Earliest CTIS Part Ii Submission Date
22-08-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
228
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Unidade Local De Saude Da Regiao De Leiria E.P.E.
Department Name
Nephrology Department
Principal Investigator Name
Joana Silva
Principal Investigator Email
joana.silva@ulsrl.min-saude.pt
Contact Person Name
Joana Silva
Contact Person Email
joana.silva@ulsrl.min-saude.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Nephrology Department
Principal Investigator Name
Ana Gomes
Principal Investigator Email
ana.gomes@ulsge.min-saude.pt
Contact Person Name
Ana Gomes
Contact Person Email
ana.gomes@ulsge.min-saude.pt
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Nephrology Department
Principal Investigator Name
Emanuel Ferreira
Principal Investigator Email
emanuelfeferreira@gmail.com
Contact Person Name
Emanuel Ferreira
Contact Person Email
emanuelfeferreira@gmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Nephrology Department
Principal Investigator Name
Raquel Vaz
Principal Investigator Email
maria.vaz@hb.min-saude.pt
Contact Person Name
Raquel Vaz
Contact Person Email
maria.vaz@hb.min-saude.pt
Site Name
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Department Name
Nephrology Department
Principal Investigator Name
Joana Vidinha
Principal Investigator Email
joana.vidinha.72810@ulsra.min-saude.pt
Contact Person Name
Joana Vidinha
Site Name
Unidade Local De Saude Da Arrabida E.P.E.
Department Name
Nephrology Department
Principal Investigator Name
Ana Farinha
Principal Investigator Email
alpfarinha@gmail.com
Contact Person Name
Ana Farinha
Contact Person Email
alpfarinha@gmail.com
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Nephrology Department
Principal Investigator Name
Eunice Cacheira
Principal Investigator Email
ecacheira@ulslo.min-saude.pt
Contact Person Name
Eunice Cacheira
Contact Person Email
ecacheira@ulslo.min-saude.pt

Belgium

Earliest CTIS Part Ii Submission Date
22-08-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
228
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
UZ Leuven
Department Name
Nephrology
Principal Investigator Name
Kathleen Claes
Principal Investigator Email
kathleen.claes@uzleuven.be
Contact Person Name
Kathleen Claes
Contact Person Email
kathleen.claes@uzleuven.be
Site Name
Jan Yperman Ziekenhuis
Department Name
Nephrology
Principal Investigator Name
Wim Terryn
Principal Investigator Email
wim.terryn@yperman.net
Contact Person Name
Wim Terryn
Contact Person Email
wim.terryn@yperman.net
Site Name
Ziekenhuis Oost Limburg
Department Name
Nephrology
Principal Investigator Name
Ben Sprangers
Principal Investigator Email
ben.sprangers@zol.be
Contact Person Name
Ben Sprangers
Contact Person Email
ben.sprangers@zol.be
Site Name
Hopital Erasme
Department Name
Nephrology
Principal Investigator Name
Tess Van Meerhaeghe
Principal Investigator Email
tess.vanmeerhaeghe@hubruxelles.be
Contact Person Name
Tess Van Meerhaeghe
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Nephrology
Principal Investigator Name
Peter Doubel
Principal Investigator Email
peter.doubel@azgroeninge.be
Contact Person Name
Peter Doubel
Contact Person Email
peter.doubel@azgroeninge.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Nephrology
Principal Investigator Name
Nathalie Demoulin
Principal Investigator Email
nathalie.demoulin@saintluc.uclouvain.be
Contact Person Name
Nathalie Demoulin

Czechia

Earliest CTIS Part Ii Submission Date
22-08-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
229
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Klinika nefrologie
Principal Investigator Name
Vladimír Tesař
Principal Investigator Email
vladimir.tesar@vfn.cz
Contact Person Name
Vladimír Tesař
Contact Person Email
vladimir.tesar@vfn.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Klinika nefrologie
Principal Investigator Name
Ondřej Viklický
Principal Investigator Email
ondrej.viklicky@ikem.cz
Contact Person Name
Ondřej Viklický
Contact Person Email
ondrej.viklicky@ikem.cz

Croatia

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
213
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Poliklinika BONIFARM
Principal Investigator Name
Ivana Vukovic Brinar
Principal Investigator Email
Ivmedex@yahoo.com
Contact Person Name
Ivana Vukovic Brinar
Contact Person Email
Ivmedex@yahoo.com
Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
Department for Nephrology and Arterial Hypertension
Principal Investigator Name
Tonko Gulin
Principal Investigator Email
tonko.gulin@gmail.com
Contact Person Name
Tonko Gulin
Contact Person Email
tonko.gulin@gmail.com
Site Name
Clinical Hospital Centre Rijeka
Department Name
Department of Nephrology, Dialysis and Kidney Transplantation
Principal Investigator Name
Ivan Bubic
Principal Investigator Email
bubic.ivan@gmail.com
Contact Person Name
Ivan Bubic
Contact Person Email
bubic.ivan@gmail.com
Site Name
Specijalna Bolnica Medico
Principal Investigator Name
Bozidar Vujicic
Principal Investigator Email
vujicic.bozidar@gmail.com
Contact Person Name
Bozidar Vujicic
Contact Person Email
vujicic.bozidar@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
21-08-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
231
Number Of Sites
6
Number Of Participants
32

Sites

Site Name
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
Department Name
Klinika Nefrologii, Transplantologii i Chorób Wewnętrznych
Principal Investigator Name
Kazimierz Ciechanowski
Principal Investigator Email
kazimierz.ciechanowski@pum.edu.pl
Contact Person Name
Kazimierz Ciechanowski
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia SCM
Principal Investigator Name
Katarzyna Bobrek-Lesiakowska
Principal Investigator Email
scm@twojaprzychodnia.com
Contact Person Name
Katarzyna Bobrek-Lesiakowska
Contact Person Email
scm@twojaprzychodnia.com
Site Name
Uniwersyteckie Centrum Kliniczne w Gdańsku
Department Name
Klinika Nefrologii, Transplantologii i Chorób Wewnętrznych
Principal Investigator Name
Sławomir Lizakowski
Principal Investigator Email
slizak@gumed.edu.pl
Contact Person Name
Sławomir Lizakowski
Contact Person Email
slizak@gumed.edu.pl
Site Name
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Department Name
Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnętrznych
Principal Investigator Name
Michał Nowicki
Principal Investigator Email
nefro@wp.pl
Contact Person Name
Michał Nowicki
Contact Person Email
nefro@wp.pl
Site Name
PRATIA MCM Kraków
Principal Investigator Name
Przemysław Miarka
Principal Investigator Email
pmiarka@pratia.pl
Contact Person Name
Przemysław Miarka
Contact Person Email
pmiarka@pratia.pl
Site Name
Scm Sp. z o.o.
Principal Investigator Name
Dariusz Aksamit
Principal Investigator Email
dariusz.aksamit@scmkrakow.pl
Contact Person Name
Dariusz Aksamit
Contact Person Email
dariusz.aksamit@scmkrakow.pl

France

Earliest CTIS Part Ii Submission Date
08-09-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
211
Number Of Sites
13
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Departemental Vendee
Department Name
Service de Néphrologie
Principal Investigator Name
Charles RONSIN
Principal Investigator Email
charles.ronsin@ght85.fr
Contact Person Name
Charles RONSIN
Contact Person Email
charles.ronsin@ght85.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Service de Néphrologie
Principal Investigator Name
Vincent VERDIER
Principal Investigator Email
vverdier@chu-reims.fr
Contact Person Name
Vincent VERDIER
Contact Person Email
vverdier@chu-reims.fr
Site Name
CHU Besancon
Department Name
Service de Néphrologie, Dialyse et Transplantation & INSERM CIC-1431
Principal Investigator Name
Melchior CHABANNES
Principal Investigator Email
mchabannes@chu-besancon.fr
Contact Person Name
Melchior CHABANNES
Contact Person Email
mchabannes@chu-besancon.fr
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Service de Néphrologie
Principal Investigator Name
François CHANTREL
Principal Investigator Email
chantrelf@ghrma.fr
Contact Person Name
François CHANTREL
Contact Person Email
chantrelf@ghrma.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Service de Néphrologie
Principal Investigator Name
Manon DEKEYSER
Principal Investigator Email
manon.deleyser@chu-orleans.fr
Contact Person Name
Manon DEKEYSER
Contact Person Email
manon.deleyser@chu-orleans.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de néphrologie, dialyse et transplantation
Principal Investigator Name
Anna DUVAL
Principal Investigator Email
anna.duval@chru-strasbourg.fr
Contact Person Name
Anna DUVAL
Contact Person Email
anna.duval@chru-strasbourg.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Néphrologie
Principal Investigator Name
Evangeline PILLEBOUT
Principal Investigator Email
evangeline.pillebout@aphp.fr
Contact Person Name
Evangeline PILLEBOUT
Contact Person Email
evangeline.pillebout@aphp.fr
Site Name
Hospital Foch
Department Name
Service de Néphrologie
Principal Investigator Name
Arwa JALAL-EDDINE
Principal Investigator Email
A.jalal-eddine@hopital-foch.com
Contact Person Name
Arwa JALAL-EDDINE
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service de Néphrologie - Dialyses - Aphèrèse
Principal Investigator Name
Olivier MORANNE
Principal Investigator Email
olivier.moranne@chu-nimes.fr
Contact Person Name
Olivier MORANNE
Contact Person Email
olivier.moranne@chu-nimes.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Service de Nephrologie et Transplantation Rénale
Principal Investigator Name
Vincent AUDARD
Principal Investigator Email
vincent.audard@aphp.fr
Contact Person Name
Vincent AUDARD
Contact Person Email
vincent.audard@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris)
Department Name
Service de Néphrologie
Principal Investigator Name
Khalil EL KAROUI
Principal Investigator Email
khalil.el-karoui@aphp.fr
Contact Person Name
Khalil EL KAROUI
Contact Person Email
khalil.el-karoui@aphp.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service de Néphrologie - Médecine Interne - Dialyse – Transplantation
Principal Investigator Name
Gabriel CHOUKROUN
Principal Investigator Email
choukroun.gabriel@chu-amiens.fr
Contact Person Name
Gabriel CHOUKROUN
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Néphrologie, Transplantation, Dialyse, Aphérèse
Principal Investigator Name
Claire RIGOTHIER
Principal Investigator Email
claire.rigothier@chu-bordeaux.fr
Contact Person Name
Claire RIGOTHIER

Germany

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
225
Number Of Sites
8
Number Of Participants
22

Sites

Site Name
Universitaet Leipzig
Department Name
Medizinische Klinik und Poliklinik für Endokrinologie, Nephrologie und Rheumatologie – Nephrologie
Principal Investigator Name
Jan Kowald
Principal Investigator Email
jan.kowald@medizin.uni-leipzig.de
Contact Person Name
Jan Kowald
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Sektion Nephrologie Klinik für Innere Medizin I
Principal Investigator Name
Bernd Schröppel
Principal Investigator Email
nephrologie@uniklinik-ulm.de
Contact Person Name
Bernd Schröppel
Contact Person Email
nephrologie@uniklinik-ulm.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Innere Medizin X, Klinik für Nephrologie
Principal Investigator Name
Claudia Sommerer
Principal Investigator Email
claudia.sommerer@med.uni-heidelberg.de
Contact Person Name
Claudia Sommerer
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Nephrologie und Internistische Intensivmedizin
Principal Investigator Name
Eva Schrezenmeier
Principal Investigator Email
eva-vanessa.schrezenmeier@charite.de
Contact Person Name
Eva Schrezenmeier
Site Name
Nephrologisches Zentrum Villingen-Schwenningen GbR
Principal Investigator Name
Bernd Hohenstein
Principal Investigator Email
b.hohenstein@nzvs.de
Contact Person Name
Bernd Hohenstein
Contact Person Email
b.hohenstein@nzvs.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik III
Principal Investigator Name
Christian Hugo
Principal Investigator Email
christian.hugo@ukdd.de
Contact Person Name
Christian Hugo
Contact Person Email
christian.hugo@ukdd.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Medizinische Klinik und Poliklinik / Nephrologie
Principal Investigator Name
Julia Weinmann-Menke
Principal Investigator Email
julia.weinmann-menke@unimedizin-mainz.de
Contact Person Name
Julia Weinmann-Menke
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik IV - Nephrologie
Principal Investigator Name
Jeannine Lang
Principal Investigator Email
Sekretariat.nephrologie@unimedizin-ffm.de
Contact Person Name
Jeannine Lang

Spain

Earliest CTIS Part Ii Submission Date
22-08-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
230
Number Of Sites
12
Number Of Participants
25

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Nephrology
Principal Investigator Name
Maria Jose Soler Romeo
Principal Investigator Email
assajos.nefrologia@vhir.org
Contact Person Name
Maria Jose Soler Romeo
Contact Person Email
assajos.nefrologia@vhir.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Nephrology
Principal Investigator Name
Alberto Ortiz Arduan
Principal Investigator Email
aortiz@fjd.es
Contact Person Name
Alberto Ortiz Arduan
Contact Person Email
aortiz@fjd.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Nephrology
Principal Investigator Name
Eduardo Gutiérrez Martínez
Principal Investigator Email
eduardogutmat90@gmail.com
Contact Person Name
Eduardo Gutiérrez Martínez
Contact Person Email
eduardogutmat90@gmail.com
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Nephrology
Principal Investigator Name
Eva López Melero
Principal Investigator Email
eva.lopez@salud.madrid.org
Contact Person Name
Eva López Melero
Contact Person Email
eva.lopez@salud.madrid.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Nephrology
Principal Investigator Name
Mercedes Salgueira Lazo
Contact Person Name
Mercedes Salgueira Lazo
Site Name
Fundacio Puigvert
Department Name
Nephrology
Principal Investigator Name
Helena Marco Rusiñol
Principal Investigator Email
hmarco@fundacio-puigvert.es
Contact Person Name
Helena Marco Rusiñol
Contact Person Email
hmarco@fundacio-puigvert.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Nephrology
Principal Investigator Name
Catuxa Rodriguez Magarinos
Principal Investigator Email
catuxa.rodriguez.magarinos@sergas.es
Contact Person Name
Catuxa Rodriguez Magarinos
Site Name
Hospital Universitario De Getafe
Department Name
Nephrology
Principal Investigator Name
Judith Fatima Martins Munoz
Principal Investigator Email
judithmartins1@gmail.com
Contact Person Name
Judith Fatima Martins Munoz
Contact Person Email
judithmartins1@gmail.com
Site Name
Hospital San Pedro De Alcantara
Department Name
Nephrology
Principal Investigator Name
Pedro Jesus Labrador Gomez
Principal Investigator Email
pedrojesus.labrador@salud-juntaex.es
Contact Person Name
Pedro Jesus Labrador Gomez
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Nephrology
Principal Investigator Name
Nadia Martin Alemany
Principal Investigator Email
nadiamartin.girona.ics@gencat.cat
Contact Person Name
Nadia Martin Alemany
Site Name
Hospital Universitario Miguel Servet
Department Name
Nephrology
Principal Investigator Name
Olga Gracia Garcia
Principal Investigator Email
nefrologia.hums@salud.aragon.es
Contact Person Name
Olga Gracia Garcia
Site Name
Hospital Del Mar
Department Name
Nephrology
Principal Investigator Name
Eva Rodriguez Garcia
Principal Investigator Email
erodrigezg@hmar.cat
Contact Person Name
Eva Rodriguez Garcia
Contact Person Email
erodrigezg@hmar.cat

Italy

Earliest CTIS Part Ii Submission Date
22-08-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
229
Number Of Sites
13
Number Of Participants
26

Sites

Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Principal Investigator Name
Vincenzo Cantaluppi
Principal Investigator Email
vincenzo.cantaluppi@uniupo.it
Contact Person Name
Vincenzo Cantaluppi
Contact Person Email
vincenzo.cantaluppi@uniupo.it
Site Name
Azienda Sanitaria Locale di Salerno
Department Name
UOC Nefrologia e dialisi
Principal Investigator Name
Giuseppe Gigliotti
Principal Investigator Email
pinogigliotti1@gmail.com
Contact Person Name
Giuseppe Gigliotti
Contact Person Email
pinogigliotti1@gmail.com
Site Name
Istituto Di Ricerche Farmacologiche Mario Negri
Department Name
Renal Diseases Department
Principal Investigator Name
Matias Trillini
Principal Investigator Email
matias.trillini@marionegri.it
Contact Person Name
Matias Trillini
Contact Person Email
matias.trillini@marionegri.it
Site Name
IRCCS Ospedale Policlinico San Martino
Principal Investigator Name
Pasquale Esposito
Principal Investigator Email
pasquale.esposito@unige.it
Contact Person Name
Pasquale Esposito
Contact Person Email
pasquale.esposito@unige.it
Site Name
Humanitas Mirasole S.p.A.
Principal Investigator Name
Gabriella Moroni
Principal Investigator Email
gabriella.moroni@hunimed.eu
Contact Person Name
Gabriella Moroni
Contact Person Email
gabriella.moroni@hunimed.eu
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Struttura Complessa di Nefrologia, Dialisi e Trapianto Renale
Principal Investigator Name
Riccardo Magistroni
Principal Investigator Email
riccardo.magistroni@unimore.it
Contact Person Name
Riccardo Magistroni
Contact Person Email
riccardo.magistroni@unimore.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UO Nefrologia
Principal Investigator Name
Federico Alberici
Principal Investigator Email
federico.alberici@unibs.it
Contact Person Name
Federico Alberici
Contact Person Email
federico.alberici@unibs.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Principal Investigator Name
Enrico Minetti
Principal Investigator Email
enrico.minetti@ospedaleniguarda.it
Contact Person Name
Enrico Minetti
Site Name
University Hospital
Department Name
Dipartimento di Medicina e Chirurgia - UO Nefrologia
Principal Investigator Name
Enrico Fiaccadori
Principal Investigator Email
enrico.fiaccadori@unipr.it
Contact Person Name
Enrico Fiaccadori
Contact Person Email
enrico.fiaccadori@unipr.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC di Nefrologia e Dialisi
Principal Investigator Name
Vittorio Di Maso
Principal Investigator Email
vittorio.dimaso@asugi.sanita.fvg.it
Contact Person Name
Vittorio Di Maso
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
UOC Nefrologia, Dialisi e Trapianto
Principal Investigator Name
Loreto Gesualdo
Principal Investigator Email
loretogesualdo.trialid@gmail.com
Contact Person Name
Loreto Gesualdo
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
Nephrology and Dialysis
Principal Investigator Name
Roberto Scarpioni
Principal Investigator Email
r.scarpioni@ausl.pc.it
Contact Person Name
Roberto Scarpioni
Contact Person Email
r.scarpioni@ausl.pc.it
Site Name
Ospedale San Giovanni Bosco
Department Name
SC Neurology
Principal Investigator Name
Roberta Fenoglio
Principal Investigator Email
roberta.fenoglio@unito.it
Contact Person Name
Roberta Fenoglio
Contact Person Email
roberta.fenoglio@unito.it

Bulgaria

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
224
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Medical Center Hera EOOD
Principal Investigator Name
Irena Dimitrova
Principal Investigator Email
irena.asenova@heraclinics.com
Contact Person Name
Irena Dimitrova
Contact Person Email
irena.asenova@heraclinics.com
Site Name
Medical Center Medconsult Pleven OOD (Lovech)
Principal Investigator Name
Diana Vasileva
Principal Investigator Email
dvasileva_mclovech@abv.bg
Contact Person Name
Diana Vasileva
Contact Person Email
dvasileva_mclovech@abv.bg
Site Name
Medical Center Medconsult Pleven OOD (Pleven)
Principal Investigator Name
Lazar Garev
Principal Investigator Email
drgarev_medconsult@abv.bg
Contact Person Name
Lazar Garev
Contact Person Email
drgarev_medconsult@abv.bg
Site Name
University Hospital St. Anna
Department Name
Nephrology department at Second Clinic of Internal Diseases
Principal Investigator Name
Boris Bogov
Principal Investigator Email
bbogov@yahoo.com
Contact Person Name
Boris Bogov
Contact Person Email
bbogov@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Nephrology Clinic
Principal Investigator Name
Atanas Kundurdjiev
Principal Investigator Email
dr.aik@abv.bg
Contact Person Name
Atanas Kundurdjiev
Contact Person Email
dr.aik@abv.bg

Sponsor

Primary sponsor

Full Name
Biogen Idec Research Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
PPD Development LP
Responsibilities
Start-up/Site Activation; Data Management/EDC; Biostats; Medical Monitoring; IRT oversight of the vendor
Name
Longboat Clinical Limited
Responsibilities
Site/patient recruitment materials
Name
Suvoda LLC
Responsibilities
eConsent, IRT
Name
Marken LLP
Responsibilities
Samples shipment

Third parties

  • {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"Safety reporting and Case management","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Site/patient recruitment materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Start-up/Site Activation; Data Management/EDC; Biostats; Medical Monitoring; IRT oversight of the vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement  / Meeting Planning","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"Anaylsis of laboratory specimens","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Marken LLP","duties_or_roles":"Samples shipment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"eConsent, IRT","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Anaylsis of laboratory specimens","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Felzartamab
Active Substance
FELZARTAMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
Intravenous
Frequency
Administered per study schedule at weeks 0, 1, 2, 3, 4, 8, 12, 16, and 20
Maximum Dose
1625 mg
Investigational Product Name
0.9% Saline
Modality
Other
Frequency
Comparator per study infusion schedule

Related trials

Other published trials that may interest you.