RecruitingPhase 2Phase 3NCT07204275

A Study to Evaluate Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)

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


Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

176 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • • 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 Criteria1

  • • Hypersensitivity to investigational medicinal product or to any of its excipients

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Interventions

DRUGPovetacicept

Solution for Subcutaneous Injection.

DRUGTacrolimus

Capsules for Oral Administration.


Locations(73)

Renal Associates

Montgomery, Alabama, United States

Southwest Kidney Institute, PLC (SKI) - Surprise

Surprise, Arizona, United States

Academic Medical Research Institute (AMRI)

Los Angeles, California, United States

Valiance Clinical Research - Internal Medicine

Tarzana, California, United States

Western Nephrology & Metabolic Bone Disease PC

Arvada, Colorado, United States

Bioresearch Partner

Miami, Florida, United States

CTR Oakwater, LLC

Orlando, Florida, United States

Clinical Site Partners, LLC - Orlando

Winter Park, Florida, United States

DaVita Clinical Research Columbus

Columbus, Georgia, United States

Georgia Nephrology

Lawrenceville, Georgia, United States

CARE Institute-Boise Kidney

Boise, Idaho, United States

NANI Research

Hinsdale, Illinois, United States

DaVita Clinical Research Edina

Edina, Minnesota, United States

Kidney Specialists of Southern Nevada

Las Vegas, Nevada, United States

Carolina Nephrology Greenville

Greenville, South Carolina, United States

Carolina Nephrology, PA

Spartanburg, South Carolina, United States

El Paso Kidney Specialists

El Paso, Texas, United States

Provecta Research Network

Houston, Texas, United States

DaVita Clinical Research Houston

Houston, Texas, United States

Davita Clinical Research San Antonio

San Antonio, Texas, United States

Utah Kidney Research

Salt Lake City, Utah, United States

Milwaukee Neprologists, SC

Wauwatosa, Wisconsin, United States

St George Private Hospital

Kogarah, Australia

University of Newcastle - John Hunter Hospital (JHH)

New Lambton Heights, Australia

Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP

São Paulo, Brazil

Beijing Tsinghua Changgung Hospital

Beijing, China

Peking University First Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Xiangya Hospital of Central South University

Changsha, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, China

Dalian Municipal Central Hospital

Dalian, China

Dongguan People's Hospital

Dongguan, China

Fuyang People's Hospital

Fuyang, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, China

The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University

Huai'an, China

The Second Qilu Hospital of Shandong University

Jinan, China

Liu Zhou Works Hospital

Liuchow, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Nanyang Central Hospital

Nanyang, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

Shanghai General Hospital

Shanghai, China

The First Hospital of Hebei Medical University

Shijiazhuang, China

The Second Hospital of Hebei Medical University

Shijiazhuang, China

Tai'an City Central Hosptial

Tai’an, China

Weifang People's Hospital

Weifang, China

Wuxi People's Hospital

Wuxi, China

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Yantai YuHuangDing Hospital

Yantai, China

Yichang Central People Hospital

Yichang, China

Charite - Universitaetsmedizin Berlin Campus Benjamin Frankl

Allemagne, Germany

Klinikum St. Georg gGmbH - Nephrology

Leipzig, Germany

Universitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Poliklinik fuer Endokrinologie, Nephrologie

Leipzig, Germany

Universitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie

Würzburg, Germany

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Hungary

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Hallym University Sacred Heart Hospital

Anyang-si, South Korea

Korea University Anam Hospital - Nephrology

Seoul, South Korea

Kyung Hee University Hospital at Gangdong - Nephrology

Seoul, South Korea

Samsung Medical Center - Nephrology

Seoul, South Korea

Severance Hospital, Yonsei University Health System - Nephrology

Seoul, South Korea

Yongin Severance Hospital - Nephrology

Yongin-si, South Korea

Hospital Universitari Vall D Hebron

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Clinica Universidad de Navarra - Nefrología

Pamplona, Spain

Hospital Universitario Virgen de la Macarena - Nefrología

Seville, Spain

University Hospital of Derby and Burton NHS Foundation Trust - Royal Derby Hospital

Derby, United Kingdom

Doncaster and Bassetlaw Hospitals NHS Foundation Trust - Doncaster Royal Infirmary

Doncaster, United Kingdom

NHS Lothian - Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

St George's University Hospitals NHS Foundation Trust - St George's Hospital- Renal Medicine

London, United Kingdom

The Royal Wolverhampton NHS Trust - New Cross Hospital

Wolverhampton, United Kingdom

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NCT07204275


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