Clinical trial • Phase II|Phase III|Phase IV • Nephrology|Rare Disease

ATACICEPT for IgA nephropathy|Membranous nephropathy|Focal segmental glomerulosclerosis|Nephrotic syndrome|Henoch-Schonlein purpura nephritis

Phase II|Phase III|Phase IV trial of ATACICEPT for IgA nephropathy|Membranous nephropathy|Focal segmental glomerulosclerosis|Nephrotic syndrome|Henoch-Sch…

Overview

Trial Therapeutic Area
Nephrology|Rare Disease
Trial Disease
IgA nephropathy|Membranous nephropathy|Focal segmental glomerulosclerosis|Nephrotic syndrome|Henoch-Schonlein purpura nephritis
Trial Stage
Phase II|Phase III|Phase IV
Drug Modality
Peptide/protein/enzyme
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
23-05-2025
First CTIS Authorization Date
08-09-2025

Trial design

open-label, adaptive Phase II|Phase III|Phase IV trial in Spain, France, Germany and others.

Open Label
Yes
Adaptive
True, enrollment and dosing for pediatric cohorts is conditional on interim PK and safety analyses and iDMC review; pediatric dose confirmation (e.g., 75 mg QW) will be determined after interim analysis; timing of initiation/termination of cohorts is at Sponsor discretion.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
126
Trial Duration For Participant
364

Eligibility

Recruits 126 paediatric patients.

Vulnerable Population
Pediatric participants are included; paediatric cohorts (IgAN-6, IgAN-8, IgAN-9) are specified with weight and age restrictions (e.g., initial enrollment restricted to ≥40 kg; enrollment of 14 to <40 kg and children aged ≥2 to <10 years deferred pending interim PK and safety analyses and iDMC review). Assent and parental/guardian consent processes are documented: pediatric assent and parental consent forms are provided (age-specific assent forms and parental ICFs, including picture-book assent for under-6s). Country-specific pediatric assent/parental ICF documents are included for multiple countries and languages.

Inclusion criteria

  • {"criterion_text":"- For All Participants: On a stable prescribed regimen of RAASi for at least 8 weeks that is at the maximum labeled or tolerated dose at Screening. (pMN-1: RAASi should be initiated per standard of care prior to Screening and should remain stable for the duration of the study; NS:RAASi, SGLT2i, MRA, ERA and/or GLP-1RA are permitted provided the dosing regimen is stable for at least 8 weeks prior to Screening and should remain stable for the duration of the study)\n- Systolic BP ≤160 mmHg and diastolic BP ≤90 mmHg at Screening.\n- Weight ≥40 kg at Screening (Weight ≥14 kg for IgAN 9 paeditric cohorts) Enrollment for pediatric participants <40 kg will open after interim analysis of PK and safety data. Enrollment of children age ≥2 to <10 years will be deferred pending interim analysis and iDMC review.\n- Willing to comply with the contraceptive guidelines of protocol\n- Additional criteria apply to each cohort/disease. Pease refer to study protocol for detailed criteria."}

Exclusion criteria

  • {"criterion_text":"- For All Participants: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 12 weeks prior to and at Screening)\n- Severe kidney impairment (eGFR <15 mL/min/1.73 m2) or receiving dialysis or kidney replacement therapy or other organ transplantation prior to, or expected during the study, with the exception of corneal transplants\n- Mixed or multiple glomerulopathies >50% tubulointerstitial fibrosis or ≥ 25% cellular crescents on biopsy\n- Active viral or bacterial infections\n- Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study\n- Administration of live and live-attenuated vaccinations within 30 days prior to enrollment\n- Known hypersensitivity to atacicept or any component of the formulated atacicept\n- Concomitant or recent immunosuppression (except post-transplant IgAN cohort)\n- Additional criteria apply to each cohort/disease. Pease refer to study protocol for detailed criteria."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- AE profile and results of routine clinical and laboratory tests through Week 52","definition_or_measurement_approach":"Assessment of adverse event (AE) profile and routine clinical and laboratory test results collected through Week 52"}
  • {"endpoint_text":"- Change from baseline in UPCR at Week 36","definition_or_measurement_approach":"Measured change from baseline in urine protein-to-creatinine ratio (UPCR) at Week 36"}
  • {"endpoint_text":"- Serum concentration of atacicept through Week 24 (pediatric cohorts IgAN-6, IgAN-8, and IgAN-9)","definition_or_measurement_approach":"Serum pharmacokinetic concentration measurements of atacicept collected through Week 24 for specified pediatric cohorts"}

Secondary endpoints

  • {"endpoint_text":"- Changes from baseline in eGFR at Weeks 36 and 52","definition_or_measurement_approach":"Change from baseline estimated glomerular filtration rate (eGFR) measured at Weeks 36 and 52"}
  • {"endpoint_text":"- Changes from baseline in Gd-IgA1 at Weeks 36 and 52 (IgAN), or anti-PLA2R antibody titer at Weeks 4, 8, 12, 36, and 52 (pMN), or anti-nephrin (NS) antibody levels at Weeks 4, 8, 12, 36 and 52","definition_or_measurement_approach":"Percent/absolute change from baseline in disease-specific biomarkers measured at specified weeks per cohort (Gd-IgA1 for IgAN; anti-PLA2R titers for pMN; anti-nephrin levels for NS)"}
  • {"endpoint_text":"- Proportion of participants achieving proteinuria responses at Weeks 24, 36, and 52","definition_or_measurement_approach":"Proportion of participants meeting predefined proteinuria response criteria at Weeks 24, 36 and 52"}
  • {"endpoint_text":"- Change from baseline in UPCR at Week 52 (IgAN cohorts), or Weeks 12, 24, and 52 (pMN and NS cohorts)","definition_or_measurement_approach":"Change from baseline in urine protein-to-creatinine ratio (UPCR) measured at cohort-specific timepoints"}
  • {"endpoint_text":"- Serum concentration of atacicept through Week 52","definition_or_measurement_approach":"Serum pharmacokinetic concentration measurements of atacicept collected through Week 52"}
  • {"endpoint_text":"- Change from baseline in PD biomarkers (serum IgG, IgA, IgM, BAFF and APRIL) levels throught Week 52","definition_or_measurement_approach":"Change from baseline in pharmacodynamic biomarkers (serum IgG, IgA, IgM, BAFF, APRIL) measured through Week 52"}

Recruitment

Planned Sample Size
126
Recruitment Window Months
59
Consent Approach
Informed consent obtained from adult participants; for minors, parental/guardian consent (parental ICF) is required plus age-appropriate assent forms. Country- and age-specific assent/consent documents exist (examples: parental ICFs and minors ICFs for Spain; assent forms 10-12 and 15-17 for France; multiple pediatric assent forms for Germany including 6-9, 10-13, 14+ and picture-book assent for under-6; Belgium and Poland have pediatric assent forms for age groups 2-5, 6-9, 10-13, 14-17). Documents are available in multiple languages corresponding to country submissions (English, French, Spanish, Italian, German, Dutch, Polish as indicated in document filenames).

Methods

  • Site-based recruitment via participating hospitals/clinics (nephrology departments) in each participating country (documents: country-specific K1 recruitment arrangements present for Spain, France, Germany, Poland, Belgium, Italy).
  • GP-letter in Italy (document K2_VT-001-0060_GP-Letter_IT_Public listed).
  • Country-specific recruitment/informed consent procedures documented (country K1/K2 files) and site referrals via participating clinical centres.
  • Patient reimbursement and site payments planned (third-party/vendor roles include patient reimbursement and site payment management as specified).

Geography

Total Number Of Sites
43
Total Number Of Participants
124

Spain

Earliest CTIS Part Ii Submission Date
11-06-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
320
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Nefrología
Contact Person Name
Ana Avila Bernabeu
Contact Person Email
avila_ana@gva.es
Site Name
Hospital Polusa S.A.
Department Name
Nefrología
Contact Person Name
Secundino Cigarran Guldris
Contact Person Email
scigarran@riberacare.com
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Nefrología
Contact Person Name
Maria Luisa Martin Conde
Contact Person Email
mlmartin.lleida.ics@gencat.cat
Site Name
Clinica Universidad De Navarra
Department Name
Nefrología
Contact Person Name
Jose Maria Mora Gutierrez
Contact Person Email
jmora@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Nefrología
Contact Person Name
Irene Agraz Pamplona
Contact Person Email
assajos.nefrologia@vhir.org
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Nefrología
Contact Person Name
Alvaro Madrid
Contact Person Email
alvaro.madrid@sjd.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Nefrología
Contact Person Name
Alberto Ortiz Arduan
Contact Person Email
AOrtiz@fjd.es
Site Name
Hospital Universitario Dr Peset Aleixandre (duplicate/other entry)
Department Name
Nefrología

France

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
245
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Néphrologie Pédiatrique
Contact Person Name
Julien Hogan
Contact Person Email
Julien.hogan2@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service de Néphrologie
Contact Person Name
Olivier MORANNE
Contact Person Email
olivier.moranne@chu-nimes.fr
Site Name
Assistance Publique Hopitaux De Paris (Sèvres address)
Department Name
Service de Néphrologie
Contact Person Name
Myriam DAO
Contact Person Email
Myriam.dai@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Néphrologie
Contact Person Name
Barbara SEITZ-POLSKI
Contact Person Email
seitz-polski.b@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service de Néphrologie
Contact Person Name
Guillaume JEANTET
Contact Person Email
g-jeantet@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service de Néphrologie
Contact Person Name
Thomas JOUVE
Contact Person Email
TJouve@chu-grenoble.f
Site Name
Assistance Publique Hopitaux De Paris (Claude Vellefaux)
Department Name
Service de Néphrologie
Contact Person Name
Evangeline PILLEBOUT
Contact Person Email
evangeline.pillebout@aphp.fr
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Service de Néphrologie
Contact Person Name
François Chantrel
Contact Person Email
CHANTRELF@ghrmsa.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Service de Néphrologie
Contact Person Name
Charles RONSIN
Contact Person Email
charles.ronsin@ght85.fr

Germany

Earliest CTIS Part Ii Submission Date
22-07-2025
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
273
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin I/Nephrologie
Contact Person Name
Lena Schulte-Kemna
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik 4, Klinik für Nephrologie
Contact Person Name
Jeannine Lang
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin
Contact Person Name
Adrian Schreiber
Contact Person Email
adrian.schreiber@charite.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Medizinische Klinik II
Contact Person Name
Claudia Seikrit
Contact Person Email
cseikrit@ukaachen.de
Site Name
Universitaet Leipzig
Department Name
Haus 4, Klinik und Poliklinik für Endokrinologie, Nephrologie und Rheumatologie – Nephrologie
Contact Person Name
Jan Kowald
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden
Department Name
Medizinische Klinik III, Bereich Nephrologie
Contact Person Name
Christian Hugo
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Nephrologie
Contact Person Name
Anja Gäckler
Contact Person Email
anja.gaeckler@uk-essen.de

Poland

Earliest CTIS Part Ii Submission Date
04-09-2025
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
229
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Katarzyna Bobrek-Lesiakowska
Contact Person Email
bobrek@twojaprzychodnia.com
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Oddzial Kliniczny Nefrologii i Pediatrii wraz z Pododdzialem Niemowlecym i Stacja Dializ
Contact Person Name
Malgorzata Mizerska-Wasiak
Site Name
Pratia S.A.
Contact Person Name
Przemysław Miarka
Contact Person Email
pmiarka@pratia.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Klinika Chorób Wewnętrznych i Nefrologii Transplantacyjnej
Contact Person Name
lona Kurnatowska
Contact Person Email
ilona.kurnatowska@umed.lodz.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorob Wewnetrznych
Contact Person Name
Michal Nowicki
Contact Person Email
nefro@wp.pl

Belgium

Earliest CTIS Part Ii Submission Date
03-09-2025
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
225
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Paediatric Nephrology and Rheumatology Department
Contact Person Name
Thomas Renson
Contact Person Email
thomas.renson@ugent.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Department of Nephrology
Contact Person Name
Ben Sprangers
Contact Person Email
ben.sprangers@zol.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Department of Nephrology
Contact Person Name
Bart Maes
Contact Person Email
bart.maes@azdelta.be
Site Name
Universitair Ziekenhuis Gent (second contact)
Department Name
Department of Nephrology
Contact Person Name
Marijn Speeckaert
Contact Person Email
marijn.speeckaert@ugent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Department of Nephrology
Contact Person Name
Nathalie Demoulin
Site Name
UZ Leuven
Department Name
Department of Nephrology
Contact Person Name
Kathleen Claes
Contact Person Email
kathleen.claes@uzleuven.be

Italy

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
256
Number Of Sites
8
Number Of Participants
29

Sites

Site Name
Universita' Degli Studi Di Napoli Federico II
Department Name
Dipartimento di Sanità Pubblica
Contact Person Name
Ivana Capuano
Contact Person Email
ivana.capuano@unina.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Unità di Nefrologia, Dialisi e Trapianto
Contact Person Name
Licia Peruzzi
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Laboratorio Nefrologia
Contact Person Name
Marina Vivarelli
Contact Person Email
marina.vivarelli@opbg.net
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC Nefrologia e Dialisi Area Giuliana
Contact Person Name
Vittorio Di Maso
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
UOC Nefrologia, Dialisi e Trapianto
Contact Person Name
Gaetano La Manna
Contact Person Email
gaetano.lamanna@unibo.it
Site Name
Istituti Clinici Scientifici Maugeri S.p.A.
Department Name
UOC di Nefrologia e Dialisi
Contact Person Name
Ciro Esposito
Contact Person Email
ciro.esposito@icsmaugeri.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
U.O.C Nefrologia, Dialisi e Trapianto
Contact Person Name
Loreto Gesualdo
Contact Person Email
controlroom@policlinico.ba.it
Site Name
Istituto Di Ricerche Farmacologiche Mario Negri
Department Name
UOC Malattie Renali
Contact Person Name
Maddalena Marasà
Contact Person Email
maddalena.marasa@marionegri.it

Sponsor

Primary sponsor

Full Name
Vera Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
Multiple CRO responsibilities including monitoring, data management, site payments and reimbursement management and other vendor tasks (codes 1,2,4,5,6,8,10,11,12,13,14,15 referenced); EUCT RInquiry.sm@ppd.com
Name
PPD Global Central Labs
Responsibilities
Central laboratory services for EU (siteservices.eu@ppd.com)
Name
Suvoda LLC
Responsibilities
Vendor services (contact orange@suvoda.com)
Name
Scout Clinical
Responsibilities
Site support / patient reimbursement related activities

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duties codes present (code:3); contact email orange@suvoda.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement (value present)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Q2BI Corp.","duties_or_roles":"Programming; other duties codes (10, 6) listed","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"France Specific - Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"EU QP Release; other duties codes (14, 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central lab services (duty code 4); siteservices.eu@ppd.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP (Wilmington address)","duties_or_roles":"Multiple vendor duties including monitoring, data management, site payments and reimbursement management (multiple codes with some textual: Site Payments and Reimbursement Management)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP (Richmond address)","duties_or_roles":"Vendor duties (duty code 4 listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fisher Bioservices Inc.","duties_or_roles":"Long Term Sample Storage (value present)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Atacicept Autoinjector Combination
Active Substance
ATACICEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
prodAuthStatus=1 (as recorded in product dictionary)
Orphan Designation
Yes
Starting Dose
150 mg QW
Dose Levels
150 mg QW
Frequency
Weekly (QW)
Maximum Dose
maxDailyDoseAmount 21.43 mg (as recorded); maxTotalDoseAmount 31287.80 (system value present)
Dose Escalation Increase
Initial dose 150 mg QW; pediatric presentation planned at 75 mg QW to be confirmed after interim analysis
Investigational Product Name
Atacicept (pre-filled syringe)
Active Substance
ATACICEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
prodAuthStatus=1 (as recorded in product dictionary)
Orphan Designation
Yes
Starting Dose
150 mg QW (PFS presentation)
Dose Levels
150 mg QW (adult); 75 mg QW (paediatric presentation pending confirmation)
Frequency
Weekly (QW)
Maximum Dose
maxDailyDoseAmount 21.43 mg (as recorded); maxTotalDoseAmount 31287.80 (system value present)
Dose Escalation Increase
Initial dose 150 mg QW; pediatric dose 75 mg QW (to be confirmed after interim analysis)

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