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

NCT ID: NCT07204275

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-12-29

Brief Summary

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

Detailed Description

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Conditions

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Primary Membranous Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phase 2b: Povetacicept

Participants will be randomized to receive one of the two doses of Povetacicept.

Group Type EXPERIMENTAL

Povetacicept

Intervention Type DRUG

Solution for Subcutaneous Injection.

Phase 3: Povetacicept

Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b).

Group Type EXPERIMENTAL

Povetacicept

Intervention Type DRUG

Solution for Subcutaneous Injection.

Phase 3: Calcineurin Inhibitor (CNI)

Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Capsules for Oral Administration.

Interventions

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Povetacicept

Solution for Subcutaneous Injection.

Intervention Type DRUG

Tacrolimus

Capsules for Oral Administration.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renal Associates

Montgomery, Alabama, United States

Site Status RECRUITING

Southwest Kidney Institute, PLC (SKI) - Surprise

Surprise, Arizona, United States

Site Status RECRUITING

Academic Medical Research Institute (AMRI)

Los Angeles, California, United States

Site Status RECRUITING

Valiance Clinical Research - Internal Medicine

Tarzana, California, United States

Site Status RECRUITING

Western Nephrology & Metabolic Bone Disease PC

Arvada, Colorado, United States

Site Status RECRUITING

Bioresearch Partner

Miami, Florida, United States

Site Status RECRUITING

CTR Oakwater, LLC

Orlando, Florida, United States

Site Status RECRUITING

Clinical Site Partners, LLC - Orlando

Winter Park, Florida, United States

Site Status RECRUITING

DaVita Clinical Research Columbus

Columbus, Georgia, United States

Site Status RECRUITING

Georgia Nephrology

Lawrenceville, Georgia, United States

Site Status RECRUITING

CARE Institute-Boise Kidney

Boise, Idaho, United States

Site Status RECRUITING

NANI Research

Hinsdale, Illinois, United States

Site Status RECRUITING

DaVita Clinical Research Edina

Edina, Minnesota, United States

Site Status RECRUITING

Kidney Specialists of Southern Nevada

Las Vegas, Nevada, United States

Site Status RECRUITING

Carolina Nephrology Greenville

Greenville, South Carolina, United States

Site Status RECRUITING

Carolina Nephrology, PA

Spartanburg, South Carolina, United States

Site Status RECRUITING

El Paso Kidney Specialists

El Paso, Texas, United States

Site Status RECRUITING

Provecta Research Network

Houston, Texas, United States

Site Status RECRUITING

DaVita Clinical Research Houston

Houston, Texas, United States

Site Status RECRUITING

Davita Clinical Research San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Utah Kidney Research

Salt Lake City, Utah, United States

Site Status RECRUITING

Milwaukee Neprologists, SC

Wauwatosa, Wisconsin, United States

Site Status RECRUITING

Peking University First Hospital

Beijing, , China

Site Status RECRUITING

Dalian Municipal Central Hospital

Dalian, , China

Site Status RECRUITING

Fuyang People's Hospital

Fuyang, , China

Site Status RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, , China

Site Status RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, , China

Site Status RECRUITING

Wuxi People's Hospital

Wuxi, , China

Site Status RECRUITING

Yichang Central People Hospital

Yichang, , China

Site Status RECRUITING

Countries

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United States China

Central Contacts

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Medical Information

Role: CONTACT

617-341-6777

Other Identifiers

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2025-521661-27-00

Identifier Type: OTHER

Identifier Source: secondary_id

VX24-AIS-D10

Identifier Type: -

Identifier Source: org_study_id

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