Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Povetacicept, Tacrolimus.
- Who it may be relevant to
- Registry conditions: Primary Membranous Nephropathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Brazil, China, Czechia +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2b/3 Adaptive, Randomized, Active-controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy
Overview
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
Interventions
- Drug Povetacicept
Solution for Subcutaneous Injection. - Drug Tacrolimus
Capsules for Oral Administration.
Primary outcome measures
- Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) [Time frame: At Week 104]
Secondary outcome measures (3)
- Proportion of Participants with Complete Clinical Remission Definition 2 (CR2) [Time frame: At Week 104]
- Proportion of Participants with Overall Clinical Remission (OR) [Time frame: At Week 104]
- Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) [Time frame: From Day 1 up to Week 112]
Eligibility criteria
Inclusion criteria
- Diagnosed with pMN with confirmatory historical biopsy. If no historical biopsy was performed that confirmed pMN, a biopsy can be performed during Screening to confirm eligibility
Exclusion criteria
- Hypersensitivity to investigational medicinal product or to any of its excipients
Other protocol defined Inclusion/Exclusion criteria will apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 34 centers
- The First Affiliated Hospital of Baotou Medical College — Baotou
- Beijing Tsinghua Changgung Hospital — Beijing
- Peking University First Hospital — Beijing
- The First Affiliated Hospital of Bengbu Medical University — Bengbu
- The Second Norman Bethune Hospital of Jilin University — Changchun
- Xiangya Hospital of Central South University — Changsha
- Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital — Chengdu
- Dalian Municipal Central Hospital — Dalian
- … and 26 more centers
United States · 24 centers
- Renal Associates — Montgomery
- Southwest Kidney Institute, PLC (SKI) - Surprise — Surprise
- Academic Medical Research Institute (AMRI) — Los Angeles
- Valiance Clinical Research - Internal Medicine — Tarzana
- Western Nephrology & Metabolic Bone Disease PC — Arvada
- Bioresearch Partner — Miami
- CTR Oakwater, LLC — Orlando
- Clinical Site Partners, LLC - Orlando — Winter Park
- … and 16 more centers
Japan · 8 centers
Center list to be confirmed — check the primary protocol.
South Korea · 7 centers
Center list to be confirmed — check the primary protocol.
Spain · 6 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 6 centers
Center list to be confirmed — check the primary protocol.
Brazil · 5 centers
- Freire Pesquisa Clinica — Belo Horizonte
- Santa Casa de Misericordia — Porto Alegre
- Universidade Federal de Pernmabuco — Recife
- Fundação Bahiana de Infectologia — Salvador
- Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP — São Paulo
Italy · 5 centers
- AOU Consorziale Policlinico di Bari - Nefrologia, Dialisi e Trapianti — Bari
- IRCCS Ospedale Policlinico San Martino — Genova
- … and 3 more centers
Australia · 4 centers
- Monash Medical Centre — Clayton
- Concord Repatriation General Hospital — Concord
- St George Private Hospital — Kogarah
- University of Newcastle - John Hunter Hospital (JHH) — New Lambton Heights
Germany · 4 centers
- Charite - Universitaetsmedizin Berlin Campus Benjamin Frankl — Allemagne
- Klinikum St. Georg gGmbH - Nephrology — Leipzig
- Universitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Polikl — Leipzig
- Universitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie — Würzburg
Ireland · 4 centers
- Cork University Hospital - Nephrology — Cork
- Beaumont Hospital — Dublin
- St. Vincent'S University Hospital — Dublin
- University Hospital Galway — Galway
Czechia · 2 centers
- FN Kralovske Vinohrady - Interni klinika — Prague
- Vseobecna fakultni nemocnice v Praze - Klinika nefrologie — Prague
Hungary · 1 center
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont — Szeged
Netherlands · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07204275 · VX24-AIS-D10 · 2025-521661-27-00