Clinical trial • Phase III • Immunology|Rare Disease

MEZAGITAMAB for Primary IgA nephropathy

Phase III trial of MEZAGITAMAB for Primary IgA nephropathy.

Overview

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

Key dates

Initial CTIS Submission Date
28-05-2025
First CTIS Authorization Date
16-09-2025

Trial design

Randomised, open-label, mezagitamab (tak-079) versus placebo (mezagitamab placebo-matching injection administered sc). dose and schedule not specified in the available part i/part ii data (randomization 2:1 allocation; dosing cycles described as 22-week dosing cycle and dosing-free period within treatment periods).-controlled Phase III trial in Austria, Czechia, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Mezagitamab (TAK-079) versus placebo (Mezagitamab placebo-matching injection administered SC). Dose and schedule not specified in the available Part I/Part II data (randomization 2:1 allocation; dosing cycles described as 22-week dosing cycle and dosing-free period within treatment periods).
Target Sample Size
264
Trial Duration For Participant
770

Eligibility

Recruits 264 Vulnerable population selected. Public documents include specific informed consent/authorization forms for pregnant partners (e.g. "Pregnant-Partner-Authorization-Form" / "ICF_Pregnant-Partn-Partic"), baby follow-up ICFs (e.g. "Baby-Follow-Up-ICF"), and caregiver/Scout consent forms (e.g. "Scout-Caregiver-ICF"). These indicate specific consent/authorization procedures for pregnant partners, infants/babies and caregivers, and separate participant information/ICF documents in multiple country languages..

Vulnerable Population
Vulnerable population selected. Public documents include specific informed consent/authorization forms for pregnant partners (e.g. "Pregnant-Partner-Authorization-Form" / "ICF_Pregnant-Partn-Partic"), baby follow-up ICFs (e.g. "Baby-Follow-Up-ICF"), and caregiver/Scout consent forms (e.g. "Scout-Caregiver-ICF"). These indicate specific consent/authorization procedures for pregnant partners, infants/babies and caregivers, and separate participant information/ICF documents in multiple country languages.

Inclusion criteria

  • {"criterion_text":"- 01. Urine protein creatinine ratio (UPCR) ≥0.8 g/g or urine protein excretion (UPE) ≥1 g/day by 24-hour urine collection.\n- 02. eGFR >30 mL/min/1.73m2 at screening based on the Chronic Kidney Disease-Epidemiology Formula\n- 03. Diagnosis of primary IgAN supported by a renal biopsy report that is dated more recently than 10 years before the signing of informed consent\n- 04. Resting blood pressure ≤150 mmHg systolic and ≤100 mmHg diastolic."}

Exclusion criteria

  • {"criterion_text":"- 01. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN\n- 02. Evidence of secondary IgAN.\n- 03. Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% eGFR within prior 3 months before consent\n- 04. Nephrotic syndrome (24-hr proteinuria >3.5 g/day or hypoalbuminemia (<3.0 g/dL) with or without peripheral edema).\n- 05. Immunosuppressant treatment within 6 months of consent.\n- 06. Anti-CD20 treatment if either within 6 months of consent or 6-12 months if CD19+ count is \n- 07. Within 4 months of the screening visist, use of either a) Systemic corticosteroids use at average dose ≥ 40mg prednisone or equivalent or higher for more than 14 days or b) use of oral budesonide delayed release capsules\n- 08. Specific infections with respective timeframes"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in proteinuria at Week 36 as assessed by a UPCR calculated from a 24-hour urine collection.","definition_or_measurement_approach":"Assessment by UPCR (urine protein creatinine ratio) calculated from a 24-hour urine collection at Week 36; change from baseline."}

Secondary endpoints

  • {"endpoint_text":"- 01. The change from baseline in eGFR at Week 52.\n- 02. The rate of change in eGFR from baseline to Week 52; eGFR total slope at Week 52.\n- 03. The change from baseline in eGFR at Week 104.\n- 04. The rate of change in eGFR from baseline to Week 104; eGFR total slope at Week 104.\n- 05. Time from baseline to the first occurrence of sustained decline in eGFR of ≥30% from baseline over at least 4 weeks.\n- 06. Time from baseline to the first occurrence of any of the following outcomes based on the kidney failure composite endpoint: sustained decline in eGFR of ≥30% from baseline over at least 4 weeks; sustained eGFR <15 mL/min/1.73 m2 over at least 4 weeks; initiation of maintenance dialysis defined as dialysis performed for at least 4 weeks; receipt of kidney transplant; or death from kidney failure (Levin et al. 2020).\n- 07. Change from baseline in proteinuria levels as assessed by UPCR calculated from a 24-hour urine collection at Week 104.\n- 08. Resolution of hematuria at Week 36.\n- 09. Resolution of hematuria at Week 52.\n- 10. Resolution of hematuria at Week 104\n- 11. Incidence of ADA.\n- 12. Incidence of NAb.\n- 13. The serum concentrations of mezagitamab during and after intervention.","definition_or_measurement_approach":"eGFR changes measured at specified weeks (Week 52, Week 104) using CKD-EPI formula; eGFR slope/rate of change over time; kidney-failure composite endpoints defined (sustained ≥30% eGFR decline over ≥4 weeks; sustained eGFR <15 mL/min/1.73 m2 over ≥4 weeks; initiation of maintenance dialysis ≥4 weeks; kidney transplant; death from kidney failure); proteinuria assessed by UPCR from 24-hour urine collections; hematuria resolution assessed at specified weeks; immunogenicity endpoints (ADA, NAb incidence) and serum mezagitamab concentrations (PK) measured during and after intervention."}

Recruitment

Registry Or Advocacy Recruitment
True, advocacy emails/letters and a 'Site-Patient-Advocacy-List' are referenced in documents (specific advocacy organisation names not specified in provided metadata).
Digital Remote Recruitment
True, includes digital ads, search ads, website copy, social media video scripts, and database/patient messaging across multiple countries (digital ad copy/visuals and social media scripts listed for Austria, Czechia, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Slovenia, Spain, Sweden).
Planned Sample Size
264
Recruitment Window Months
27
Consent Approach
Informed consent provided by adult participants (main ICF documents present). Separate consent/authorization documents exist for pregnant partners (Pregnant-Partner-Authorization / Pregnancy ICF), baby follow-up (Baby-Follow-Up-ICF) and caregiver/scout situations (Scout/Caregiver ICF). Main ICFs and supporting consent materials are provided in multiple country languages (documents available in English, German, Czech, French, Italian, Dutch, Norwegian, Polish, Spanish, Slovenian, Swedish, Hungarian in the public document list).

Methods

  • Digital advertising: digital ad copy and visuals, search ads, and website copy (country-specific assets listed for Austria, Czechia, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Slovenia, Spain, Sweden) targeting the general public/potential patients.
  • Social media: social-media video scripts and materials for public-facing recruitment (country-specific assets present).
  • HCP outreach: Doctor-to-Doctor emails, HCP-to-colleague presentations, and GP letters to engage healthcare professionals and refer patients (country-specific HCP materials present).
  • Direct-to-patient outreach: Doctor-to-Patient emails, database/patient messaging, participant study guides, recruitment brochures, flyers, posters and study listings (materials exist per country).
  • Advocacy engagement: Advocacy emails and advocacy letters (country-specific advocacy materials present) to engage patient/advocacy communities.
  • Site-based recruitment: Site patient-facing materials and site-specific recruitment arrangements (site lists and site patient advocacy list referenced).
  • Scout/third-party recruitment support: Scout Clinical and Clinical Trial Media referenced for patient reimbursement and recruitment support.

Geography

Total Number Of Sites
50
Total Number Of Participants
83

Austria

Earliest CTIS Part Ii Submission Date
11-09-2025
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
11
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Johannes Kepler University Linz
Department Name
Department of Internal Medicine and Christian Doppler Laboratoryfor Mucosa Immunology, Med.CampusIII
Principal Investigator Name
Alexander Moschen
Principal Investigator Email
alexander.moschen@kepleruniklinikum.at
Contact Person Name
Alexander Moschen
Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine III, Division of Nephrology and Dialysis
Principal Investigator Name
Rainer Oberbauer
Principal Investigator Email
rainer.oberbauer@meduniwien.ac.at
Contact Person Name
Rainer Oberbauer

Czechia

Earliest CTIS Part Ii Submission Date
10-09-2025
Latest Decision Or Authorization Date
17-09-2025
Processing Time Days
7
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
University Hospital Olomouc
Department Name
III. Interní klinika-nefrologická, revmatologická a endokrinologická
Principal Investigator Name
Karel Krejčí
Principal Investigator Email
Karel.Krejci@fnol.cz
Contact Person Name
Karel Krejčí
Contact Person Email
Karel.Krejci@fnol.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Hemodialyzační ambulance
Principal Investigator Name
Václava Honová
Principal Investigator Email
Vaclava.Honova@nnj.agel.cz
Contact Person Name
Václava Honová
Contact Person Email
Vaclava.Honova@nnj.agel.cz
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

France

Earliest CTIS Part Ii Submission Date
10-09-2025
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
12
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service de Néphrologie et Transplantation
Principal Investigator Name
Fatouma TOURE
Principal Investigator Email
fatouma.toure@chu-limoges.fr
Contact Person Name
Fatouma TOURE
Contact Person Email
fatouma.toure@chu-limoges.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Service de Néphrologie et Transplantation Rénale
Principal Investigator Name
Vincent AUDARD
Principal Investigator Email
vincent.audard@aph.fr
Contact Person Name
Vincent AUDARD
Contact Person Email
vincent.audard@aph.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris)
Department Name
Département 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 De Bordeaux
Department Name
Service de néphrologie, transplantation, dialyse, aphérèses
Principal Investigator Name
Claire RIGOTHIER
Principal Investigator Email
claire.rigothier@chu-bordeaux.fr
Contact Person Name
Claire RIGOTHIER
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service Néphrologie
Principal Investigator Name
Moglie LE QUINTREC-DONNETTE
Principal Investigator Email
m-lequintrec-donnette@chu-montpellier.fr
Contact Person Name
Moglie LE QUINTREC-DONNETTE
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service de Néphrologie et Immunologie
Principal Investigator Name
Simon VILLE
Principal Investigator Email
simon.ville@chu-nantes.fr
Contact Person Name
Simon VILLE
Contact Person Email
simon.ville@chu-nantes.fr

Italy

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
7
Number Of Sites
9
Number Of Participants
9

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
SC Nephrology, Dialysis and Transplantation
Principal Investigator Name
Federica Mescia
Principal Investigator Email
federica.mescia@unibs.it
Contact Person Name
Federica Mescia
Contact Person Email
federica.mescia@unibs.it
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
UOC Nefrologia e Dialisi
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
Istituti Clinici Scientifici Maugeri S.p.A. (Pavia)
Department Name
UOC di Nefrologia e Dialisi
Principal Investigator Name
Ciro Esposito
Principal Investigator Email
ciro.esposito@icsmaugeri.it
Contact Person Name
Ciro Esposito
Contact Person Email
ciro.esposito@icsmaugeri.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica Nefrologica Dialisi e Trapianto
Principal Investigator Name
Francesca Chiara Viazzi
Principal Investigator Email
Francesca.viazzi@unige.it
Contact Person Name
Francesca Chiara Viazzi
Contact Person Email
Francesca.viazzi@unige.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
U.O.C. nefrologia, dialisi e trapianto
Principal Investigator Name
Loreto Gesualdo
Principal Investigator Email
Loreto.gesualdo@uniba.it
Contact Person Name
Loreto Gesualdo
Contact Person Email
Loreto.gesualdo@uniba.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C Nefrologia, dialisi e trapianto renale
Principal Investigator Name
Luigi Biancone
Principal Investigator Email
luigi.biancone@unito.it
Contact Person Name
Luigi Biancone
Contact Person Email
luigi.biancone@unito.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Nefrologia, Dialisi e Trapianto di Rene
Principal Investigator Name
Giuseppe Castellano
Principal Investigator Email
giuseppe.castellano@policlinico.mi.it
Contact Person Name
Giuseppe Castellano
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Unità di Nefrologia, Dialisi e Trapianto
Principal Investigator Name
Gaetano La Manna
Principal Investigator Email
gaetano.lamanna@unibo.it
Contact Person Name
Gaetano La Manna
Contact Person Email
gaetano.lamanna@unibo.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
U.O.C. Nefrologia e Dialisi - D.A.I. Scienze Mediche
Principal Investigator Name
Domenico Santoro
Principal Investigator Email
domenico.santoro@unime.it
Contact Person Name
Domenico Santoro
Contact Person Email
domenico.santoro@unime.it

Sweden

Earliest CTIS Part Ii Submission Date
08-09-2025
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
8
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Region Oestergoetland (Universitetssjukhuset I)
Department Name
Njurmedicin mottagningen US
Principal Investigator Name
Annette Bruchfeld
Principal Investigator Email
Annette.bruchfeld@liu.se
Contact Person Name
Annette Bruchfeld
Contact Person Email
Annette.bruchfeld@liu.se

Netherlands

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
7
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Internal Medicine and Dermatology, Nephrology
Principal Investigator Name
Sabine Meijvis
Principal Investigator Email
s.c.a.meijvis@umcutrecht.nl
Contact Person Name
Sabine Meijvis
Contact Person Email
s.c.a.meijvis@umcutrecht.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Nephrology
Principal Investigator Name
Raphael Duivenvoorden
Principal Investigator Email
raphael.duivenvoorden@radboudumc.nl
Contact Person Name
Raphael Duivenvoorden
Site Name
St. Antonius Ziekenhuis
Department Name
Hemodialyzační ambulance
Principal Investigator Name
Gurbey Ocak
Principal Investigator Email
g.ocak@antoniusziekenhuis.nl
Contact Person Name
Gurbey Ocak
Contact Person Email
g.ocak@antoniusziekenhuis.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Internal Medicine and Nephrology
Principal Investigator Name
Joris Rotmans
Principal Investigator Email
j.i.rotmans@lumc.nl
Contact Person Name
Joris Rotmans
Contact Person Email
j.i.rotmans@lumc.nl
Site Name
Academisch Medisch Centrum
Department Name
Nephrology
Principal Investigator Name
Marc Hilhorst
Principal Investigator Email
m.l.hilhorst@amsterdamumc.nl
Contact Person Name
Marc Hilhorst
Contact Person Email
m.l.hilhorst@amsterdamumc.nl

Norway

Earliest CTIS Part Ii Submission Date
08-09-2025
Latest Decision Or Authorization Date
18-09-2025
Processing Time Days
10
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Helse Stavanger HF
Department Name
Mottaksklinikk
Principal Investigator Name
Lasse Goransson
Principal Investigator Email
Lasse.gunnar.goransson@sus.no
Contact Person Name
Lasse Goransson
Contact Person Email
Lasse.gunnar.goransson@sus.no
Site Name
Helse Bergen HF
Department Name
Medisinsk Klinikk
Principal Investigator Name
Thomas Knoop
Principal Investigator Email
Thomas.knoop@helse-bergen.no
Contact Person Name
Thomas Knoop
Contact Person Email
Thomas.knoop@helse-bergen.no
Site Name
Sykehuset I Vestfold HF
Department Name
Medisinsk Klinikk
Principal Investigator Name
Stig Arne Kjellevold
Principal Investigator Email
stig.arne.kjellevold@siv.no
Contact Person Name
Stig Arne Kjellevold
Contact Person Email
stig.arne.kjellevold@siv.no
Site Name
Sykehuset Ostfold HF
Department Name
Nyremedisinsk Poliklinikk
Principal Investigator Name
Ioana-Elena Dumitrescu
Principal Investigator Email
Ioana.elena.dumitrescu@so-hf.no
Contact Person Name
Ioana-Elena Dumitrescu
Site Name
Akershus University Hospital
Department Name
Nyremedisinsk Avdeling
Principal Investigator Name
Bartlomiej Witczak
Principal Investigator Email
barwit@ahus.no
Contact Person Name
Bartlomiej Witczak
Contact Person Email
barwit@ahus.no
Site Name
St. Olavs Hospital HF
Department Name
Medisinsk Klinikk
Principal Investigator Name
Yngvar Haaskjold
Principal Investigator Email
Yngvar.lunde.haaskjold@stolav.no
Contact Person Name
Yngvar Haaskjold

Poland

Earliest CTIS Part Ii Submission Date
08-09-2025
Latest Decision Or Authorization Date
19-09-2025
Processing Time Days
11
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Nowy Szpital Sp. z o.o.
Department Name
Stacja Dializ, Oddzial Nefrologiczny
Principal Investigator Name
Andrzej Brymora
Principal Investigator Email
ABrymora@nowyszpital.pl
Contact Person Name
Andrzej Brymora
Contact Person Email
ABrymora@nowyszpital.pl
Site Name
Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnętrznych
Principal Investigator Name
Michal Nowicki
Principal Investigator Email
nefro@wp.pl
Contact Person Name
Michal Nowicki
Contact Person Email
nefro@wp.pl
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika (Wroclaw)
Principal Investigator Name
Magdalena Krajewska
Principal Investigator Email
badaniakliniczne@4wsk.pl
Contact Person Name
Magdalena Krajewska
Contact Person Email
badaniakliniczne@4wsk.pl
Site Name
Scm Sp. z o.o. (Cracow)
Principal Investigator Name
Dariusz Aksamit
Principal Investigator Email
daksamit@poczta.onet.pl
Contact Person Name
Dariusz Aksamit
Contact Person Email
daksamit@poczta.onet.pl

Slovenia

Earliest CTIS Part Ii Submission Date
21-08-2025
Latest Decision Or Authorization Date
18-09-2025
Processing Time Days
28
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
University Medical Center Ljubljana
Principal Investigator Name
Andreja Aleš Rigler
Principal Investigator Email
andreja.ales@kclj.si
Contact Person Name
Andreja Aleš Rigler
Contact Person Email
andreja.ales@kclj.si
Site Name
UNIVERZITETNI KLINICNI CENTER MARIBOR
Principal Investigator Name
Sebastjan Bevc
Principal Investigator Email
Sebastjan.bevc@ukc-mb.si
Contact Person Name
Sebastjan Bevc
Contact Person Email
Sebastjan.bevc@ukc-mb.si

Germany

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
17-09-2025
Processing Time Days
16
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Universitaetsklinikum Aachen AöR
Department Name
Medizinische Klinik II
Principal Investigator Name
Claudia Seikrit
Principal Investigator Email
cseikrit@ukaachen.de
Contact Person Name
Claudia Seikrit
Contact Person Email
cseikrit@ukaachen.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin III, Fachbereich Nephrologie
Principal Investigator Name
Martin Busch
Principal Investigator Email
martin.busch@med.uni-jena.de
Contact Person Name
Martin Busch
Contact Person Email
martin.busch@med.uni-jena.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. 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

Spain

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
7
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Hospital Universitario De Cruces
Department Name
Nephrology
Principal Investigator Name
Laura Bueno López
Principal Investigator Email
laura.buenolopez@osakidetza.eus
Contact Person Name
Laura Bueno López
Site Name
Hospital Del Mar
Department Name
Nephrology
Principal Investigator Name
Eva Rodríguez García
Principal Investigator Email
erodriguezg@hmar.cat
Contact Person Name
Eva Rodríguez García
Contact Person Email
erodriguezg@hmar.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Nephrology
Principal Investigator Name
Manuel López Mendoza
Principal Investigator Email
lolopezmen@gmail.com
Contact Person Name
Manuel López Mendoza
Contact Person Email
lolopezmen@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Nephrology
Principal Investigator Name
Irene Agraz Pamplona
Principal Investigator Email
assajos.nefrologia@vhir.org
Contact Person Name
Irene Agraz Pamplona
Contact Person Email
assajos.nefrologia@vhir.org
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Nephrology
Principal Investigator Name
José María Mora Gutiérrez
Principal Investigator Email
ensayoscun@unav.es
Contact Person Name
José María Mora Gutiérrez
Contact Person Email
ensayoscun@unav.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Nephrology
Principal Investigator Name
Iara Karlla Da Silva Santos
Principal Investigator Email
isilvasa.germanstrias@gencat.cat
Contact Person Name
Iara Karlla Da Silva Santos
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Nephrology
Principal Investigator Name
Alberto Ortiz Arduán
Principal Investigator Email
aortiz@fjd.es
Contact Person Name
Alberto Ortiz Arduán
Contact Person Email
aortiz@fjd.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Nephrology
Principal Investigator Name
José María Mora Gutiérrez
Principal Investigator Email
ensayoscun@unav.es
Contact Person Name
José María Mora Gutiérrez
Contact Person Email
ensayoscun@unav.es

Hungary

Earliest CTIS Part Ii Submission Date
10-09-2025
Latest Decision Or Authorization Date
18-09-2025
Processing Time Days
8
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Semmelweis University
Department Name
Belgyógyászati és Onkológiai Klinika, Klinikai Farmakológiai Részleg
Principal Investigator Name
PETHŐ Ákos Géza
Principal Investigator Email
petho.akos@semmelweis.hu
Contact Person Name
PETHŐ Ákos Géza
Contact Person Email
petho.akos@semmelweis.hu

Sponsor

Primary sponsor

Full Name
Takeda Development Center Americas Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Development Solutions LLC
Responsibilities
sponsorDuties code 4 (responsibility detail not specified in metadata)
Name
IQVIA Limited
Responsibilities
eCOA (electronic clinical outcome assessment) per sponsorDuties value
Name
Pharmaceutical Product Development LLC
Responsibilities
multiple operational roles (sponsorDuties codes 1,12,13,5) including clinical supply/operations/data (codes provided; textual mapping not provided in metadata)
Name
Endpoint Clinical Inc.
Responsibilities
sponsorDuties code 3 (role not textually specified in metadata)

Third parties

  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"sponsorDuties codes: 4 (no textual role provided in metadata)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"eCOA (sponsorDuties code 15; value: eCOA)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 1, 12, 13, 5 (roles not textually specified in metadata)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties code: 3 (responsibility code only)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Recruitment (sponsorDuties code 15; value: Recruitment)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Pharma Services LLC","duties_or_roles":"IP supply (sponsorDuties code 15; value: IP supply)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Trial Master File and Clinical Trial Management System (sponsorDuties codes: 15 value: Trial Master File and Clinical Trial Management System; and code 7)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement (sponsorDuties code 15; value: Patient reimbursement)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4 (role not textually specified in metadata)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Mezagitamab
Active Substance
MEZAGITAMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
prodAuthStatus=1 (as provided in productDictionaryInfo)
Investigational Product Name
Mezagitamab placebo-matching injection administered SC
Combination Treatment
Yes

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