What this study is
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
What's being tested
- Povetacicept
Intervention · DRUG
Solution for Subcutaneous Injection.
- Tacrolimus
Intervention · DRUG
Capsules for Oral Administration.
Study details
- 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
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Conditions
- Primary Membranous Nephropathy
- Enrolling
- 176 people
- Starts
- 2025-09-30
- Est. completion
- 2028-12-29
- Design
- Quadruple-blind, randomized, sequential groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Hypersensitivity to investigational medicinal product or to any of its excipients
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (117)
116 openRenal Associates
Montgomery, Alabama, United States
RecruitingSouthwest Kidney Institute, PLC (SKI) - Surprise
Surprise, Arizona, United States
RecruitingAcademic Medical Research Institute (AMRI)
Los Angeles, California, United States
RecruitingKaiser Permanente Sacramento Medical Center
Sacramento, California, United States
RecruitingValiance Clinical Research - Internal Medicine
Tarzana, California, United States
RecruitingWestern Nephrology & Metabolic Bone Disease PC
Arvada, Colorado, United States
RecruitingBioresearch Partner
Miami, Florida, United States
RecruitingCTR Oakwater, LLC
Orlando, Florida, United States
RecruitingClinical Site Partners, LLC - Orlando
Winter Park, Florida, United States
RecruitingDaVita Clinical Research Columbus
Columbus, Georgia, United States
RecruitingGeorgia Nephrology
Lawrenceville, Georgia, United States
RecruitingCARE Institute-Boise Kidney
Boise, Idaho, United States
RecruitingNANI Research
Hinsdale, Illinois, United States
RecruitingNephrology Associates of Northern Illinois and Indiana (NANI) - Indianapolis South
Indianapolis, Indiana, United States
RecruitingNorthwest Louisiana Nephrology, LLC - Shreveport
Shreveport, Louisiana, United States
RecruitingDaVita Clinical Research Edina
Edina, Minnesota, United States
RecruitingSt. Clair Nephrology Research
Roseville, Missouri, United States
RecruitingKidney Specialists of Southern Nevada
Las Vegas, Nevada, United States
RecruitingNYU Medical Center
New York, New York, United States
RecruitingMetrolina Nephrology Associates, PA
Gastonia, North Carolina, United States
RecruitingCarolina Nephrology Greenville
Greenville, South Carolina, United States
RecruitingCarolina Nephrology, PA
Spartanburg, South Carolina, United States
RecruitingEl Paso Kidney Specialists
El Paso, Texas, United States
RecruitingProvecta Research Network
Houston, Texas, United States
RecruitingDaVita Clinical Research Houston
Houston, Texas, United States
RecruitingDavita Clinical Research San Antonio
San Antonio, Texas, United States
RecruitingUtah Kidney Research
Salt Lake City, Utah, United States
RecruitingMilwaukee Neprologists, SC
Wauwatosa, Wisconsin, United States
Recruiting
89 sites outside the US
Monash Medical Centre
Clayton, Australia
RecruitingConcord Repatriation General Hospital
Concord, Australia
RecruitingSt George Private Hospital
Kogarah, Australia
RecruitingUniversity of Newcastle - John Hunter Hospital (JHH)
New Lambton Heights, Australia
RecruitingFreire Pesquisa Clinica
Belo Horizonte, Brazil
RecruitingHospital das Clinicas da Universidade Federal de Goias
Goiânia, Brazil
RecruitingSanta Casa de Misericordia
Porto Alegre, Brazil
RecruitingUniversidade Federal de Pernmabuco
Recife, Brazil
RecruitingFundação Bahiana de Infectologia
Salvador, Brazil
RecruitingHospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP
São Paulo, Brazil
RecruitingThe First Affiliated Hospital of Baotou Medical College
Baotou, China
RecruitingBeijing Tsinghua Changgung Hospital
Beijing, China
RecruitingPeking University First Hospital
Beijing, China
RecruitingThe First Affiliated Hospital of Bengbu Medical University
Bengbu, China
RecruitingThe Second Norman Bethune Hospital of Jilin University
Changchun, China
RecruitingXiangya Hospital of Central South University
Changsha, China
RecruitingSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, China
RecruitingDalian Municipal Central Hospital
Dalian, China
RecruitingDongguan People's Hospital
Dongguan, China
RecruitingFuyang People's Hospital
Fuyang, China
RecruitingGuangdong Provincial People's Hospital
Guangzhou, China
RecruitingThe 2nd Affiliated Hospital of Harbin Medical University
Harbin, China
RecruitingThe Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University
Huai'an, China
RecruitingThe Second Qilu Hospital of Shandong University
Jinan, China
RecruitingLiu Zhou Works Hospital
Liuzhou, China
RecruitingThe First Affiliated Hospital of Nanchang University
Nanchang, China
RecruitingThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
RecruitingNanyang Central Hospital
Nanyang, China
RecruitingThe First Affiliated Hospital of Ningbo University
Ningbo, China
RecruitingRenji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
RecruitingShanghai General Hospital
Shanghai, China
RecruitingShenjing Hospital of China Medical University
Shenyang, China
RecruitingThe First Hospital of Hebei Medical University
Shijiazhuang, China
RecruitingThe Fourth Hospital of Hebei Medical University
Shijiazhuang, China
RecruitingThe Fourth Hospital of Hebei Medical Univesrsity
Shijiazhuang, China
RecruitingThe Second Hospital of Hebei Medical University
Shijiazhuang, China
RecruitingTai'an City Central Hosptial
Tai’an, China
RecruitingWeifang People's Hospital
Weifang, China
RecruitingWuxi People's Hospital
Wuxi, China
RecruitingThe First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, China
RecruitingThe First Affiliated Hospital of Xiamen University
Xiamen, China
RecruitingYantai YuHuangDing Hospital
Yantai, China
RecruitingYichang Central People Hospital
Yichang, China
RecruitingFN Kralovske Vinohrady - Interni klinika
Prague, Czechia
RecruitingVseobecna fakultni nemocnice v Praze - Klinika nefrologie
Prague, Czechia
RecruitingCharite - Universitaetsmedizin Berlin Campus Benjamin Frankl
Allemagne, Germany
RecruitingKlinikum St. Georg gGmbH - Nephrology
Leipzig, Germany
RecruitingUniversitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Poliklinik fuer Endokrinologie, Nephrologie
Leipzig, Germany
RecruitingUniversitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie
Würzburg, Germany
RecruitingSzegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary
RecruitingCork University Hospital - Nephrology
Cork, Ireland
RecruitingBeaumont Hospital
Dublin, Ireland
RecruitingSt. Vincent'S University Hospital
Dublin, Ireland
RecruitingUniversity Hospital Galway
Galway, Ireland
RecruitingAOU Consorziale Policlinico di Bari - Nefrologia, Dialisi e Trapianti
Bari, Italy
RecruitingIRCCS Ospedale Policlinico San Martino
Genova, Italy
RecruitingAzienda Ospedaliera Universitaria Federico II
Naples, Italy
RecruitingFondazione IRCCS Policlinico San Matteo
Pavia, Italy
RecruitingFondazione Salvatore Maugeri - Nefrologia e Dialisi
Pavia, Italy
RecruitingKanazawa University Hospital
Kanazawa, Japan
RecruitingKasugai Municipal Hospital
Kasugai, Japan
RecruitingSt.Marianna University School of Medicine Hospital
Kawasaki-shi, Japan
RecruitingOkayama University Hospital
Okayama, Japan
RecruitingNagoya University Hospital
Shōwaku, Japan
RecruitingThe University of Osaka Hospital
Suita, Japan
RecruitingFujita Health University
Toyoake-Shi, Japan
RecruitingJuntendo University Urayasu Hospital
Urayasu, Japan
RecruitingAmsterdam UMC - Nephrology
Amsterdam, Netherlands
RecruitingRadboud universitair medisch centrum / RADBOUDUMC - Nephrology
Nijmegen, Netherlands
RecruitingHallym University Sacred Heart Hospital
Anyang-si, South Korea
RecruitingKorea University Anam Hospital - Nephrology
Seoul, South Korea
RecruitingKorea University Guro Hospital - Nephrology
Seoul, South Korea
RecruitingKyung Hee University Hospital at Gangdong - Nephrology
Seoul, South Korea
RecruitingSamsung Medical Center - Nephrology
Seoul, South Korea
RecruitingSeverance Hospital, Yonsei University Health System - Nephrology
Seoul, South Korea
RecruitingYongin Severance Hospital - Nephrology
Yongin-si, South Korea
RecruitingHospital Universitari Vall D Hebron
Barcelona, Spain
RecruitingHospital Universitario Reina Sofia
Córdoba, Spain
RecruitingHospital de Vinalopó
Elche, Spain
RecruitingHospital Ribera Polusa
Lugo, Spain
RecruitingClinica Universidad de Navarra - Nefrología
Pamplona, Spain
RecruitingHospital Universitario Virgen de la Macarena - Nefrología
Seville, Spain
RecruitingUniversity Hospital of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
Derby, United Kingdom
RecruitingDoncaster and Bassetlaw Hospitals NHS Foundation Trust - Doncaster Royal Infirmary
Doncaster, United Kingdom
RecruitingNHS Lothian - Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
RecruitingImperial College Healthcare NHS Trust - Hammersmith Hospital
London, United Kingdom
RecruitingSt George's University Hospitals NHS Foundation Trust - St George's Hospital- Renal Medicine
London, United Kingdom
RecruitingThe Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton, United Kingdom
RecruitingThe First Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
Withdrawn
Study team
Sponsor
Vertex Pharmaceuticals Incorporated
Study ID VX24-AIS-D10
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.