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
Status: Recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• • 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
Locations
United States
Alabama
Renal Associates
RECRUITING
Montgomery
Arizona
Southwest Kidney Institute, PLC (SKI) - Surprise
RECRUITING
Surprise
California
Academic Medical Research Institute (AMRI)
RECRUITING
Los Angeles
Valiance Clinical Research - Internal Medicine
RECRUITING
Tarzana
Colorado
Western Nephrology & Metabolic Bone Disease PC
RECRUITING
Arvada
Florida
Bioresearch Partner
RECRUITING
Miami
CTR Oakwater, LLC
RECRUITING
Orlando
Clinical Site Partners, LLC - Orlando
RECRUITING
Winter Park
Georgia
DaVita Clinical Research Columbus
RECRUITING
Columbus
Georgia Nephrology
RECRUITING
Lawrenceville
Idaho
CARE Institute-Boise Kidney
RECRUITING
Boise
Illinois
NANI Research
RECRUITING
Hinsdale
Minnesota
DaVita Clinical Research Edina
RECRUITING
Edina
Nevada
Kidney Specialists of Southern Nevada
RECRUITING
Las Vegas
South Carolina
Carolina Nephrology Greenville
RECRUITING
Greenville
Carolina Nephrology, PA
RECRUITING
Spartanburg
Texas
El Paso Kidney Specialists
RECRUITING
El Paso
DaVita Clinical Research Houston
RECRUITING
Houston
Provecta Research Network
RECRUITING
Houston
Davita Clinical Research San Antonio
RECRUITING
San Antonio
Utah
Utah Kidney Research
RECRUITING
Salt Lake City
Wisconsin
Milwaukee Neprologists, SC
RECRUITING
Wauwatosa
Other Locations
Australia
St George Private Hospital
RECRUITING
Kogarah
University of Newcastle - John Hunter Hospital (JHH)
RECRUITING
New Lambton Heights
Brazil
Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP
RECRUITING
São Paulo
China
Beijing Tsinghua Changgung Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical University
RECRUITING
Bengbu
Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Dalian Municipal Central Hospital
RECRUITING
Dalian
Dongguan People's Hospital
RECRUITING
Dongguan
Fuyang People's Hospital
RECRUITING
Fuyang
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital,Sun Yat-sen University
RECRUITING
Guangzhou
The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University
RECRUITING
Huai'an
The Second Qilu Hospital of Shandong University
RECRUITING
Jinan
Liu Zhou Works Hospital
RECRUITING
Liuchow
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Nanyang Central Hospital
RECRUITING
Nanyang
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Shanghai General Hospital
RECRUITING
Shanghai
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Tai'an City Central Hosptial
RECRUITING
Tai’an
Weifang People's Hospital
RECRUITING
Weifang
Wuxi People's Hospital
RECRUITING
Wuxi
The First Affiliated Hospital of Xi 'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Yantai YuHuangDing Hospital
RECRUITING
Yantai
Yichang Central People Hospital
RECRUITING
Yichang
Germany
Charite - Universitaetsmedizin Berlin Campus Benjamin Frankl
RECRUITING
Allemagne
Klinikum St. Georg gGmbH - Nephrology
RECRUITING
Leipzig
Universitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Poliklinik fuer Endokrinologie, Nephrologie
RECRUITING
Leipzig
Universitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie
RECRUITING
Würzburg
Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
RECRUITING
Szeged
Italy
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang-si
Korea University Anam Hospital - Nephrology
RECRUITING
Seoul
Kyung Hee University Hospital at Gangdong - Nephrology
RECRUITING
Seoul
Samsung Medical Center - Nephrology
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System - Nephrology
RECRUITING
Seoul
Yongin Severance Hospital - Nephrology
RECRUITING
Yongin-si
Spain
Hospital Universitari Vall D Hebron
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Clinica Universidad de Navarra - Nefrología
RECRUITING
Pamplona
Hospital Universitario Virgen de la Macarena - Nefrología
RECRUITING
Seville
United Kingdom
University Hospital of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
RECRUITING
Derby
Doncaster and Bassetlaw Hospitals NHS Foundation Trust - Doncaster Royal Infirmary
RECRUITING
Doncaster
NHS Lothian - Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
St George's University Hospitals NHS Foundation Trust - St George's Hospital- Renal Medicine
RECRUITING
London
The Royal Wolverhampton NHS Trust - New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2028-12-29
Participants
Target number of participants: 176
Treatments
Experimental: Phase 2b: Povetacicept
Participants will be randomized to receive one of the two doses of Povetacicept.
Experimental: Phase 3: Povetacicept
Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b).
Active_comparator: Phase 3: Calcineurin Inhibitor (CNI)
Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.
Related Therapeutic Areas
Sponsors
Collaborators: Zai Lab (Shanghai) Co., Ltd. (for China only)
Leads: Vertex Pharmaceuticals Incorporated