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 (25) 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
China
Peking University First Hospital
RECRUITING
Beijing
Wuxi People's Hospital
RECRUITING
Wuxi
Yichang Central People Hospital
RECRUITING
Yichang
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
Leads: Vertex Pharmaceuticals Incorporated