Recruiting

Phase 2

Phase 3

PovetaciceptEvaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07204275

Conditions

Primary Membranous Nephropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Povetacicept

Tacrolimus

Study Details

Brief summary:

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

Conditions

Primary Membranous Nephropathy

Study ID

NCT07204275

Start date

Sep 30, 2025

Status verified date

Sep, 2026

Completion date

Dec 29, 2028

Anticipated

Primary completion date

Dec 29, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key 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

Key Exclusion Criteria:

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

Other protocol defined Inclusion/Exclusion criteria will apply

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Povetacicept

Solution for Subcutaneous Injection.

Tacrolimus

Capsules for Oral Administration.

Primary outcome measure

Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) [ Time Frame: At Week 104 ]

Central Contacts and Locations

Central contacts

Medical Information

001-617-341-6777 medicalinfo@vrtx.com

Locations

Renal Associates

Recruiting

Montgomery, Alabama, United States, 36117

Southwest Kidney Institute, PLC (SKI) - Surprise

Recruiting

Surprise, Arizona, United States, 85374

Academic Medical Research Institute (AMRI)

Recruiting

Los Angeles, California, United States, 90022

Kaiser Permanente Sacramento Medical Center

Recruiting

Sacramento, California, United States, 95825

Valiance Clinical Research - Internal Medicine

Recruiting

Tarzana, California, United States, 91356

Western Nephrology & Metabolic Bone Disease PC

Recruiting

Arvada, Colorado, United States, 80002

Bioresearch Partner

Recruiting

Miami, Florida, United States, 33127

CTR Oakwater, LLC

Recruiting

Orlando, Florida, United States, 32806

Clinical Site Partners, LLC - Orlando

Recruiting

Winter Park, Florida, United States, 32789

DaVita Clinical Research Columbus

Recruiting

Columbus, Georgia, United States, 31904

Georgia Nephrology

Recruiting

Lawrenceville, Georgia, United States, 30046

CARE Institute-Boise Kidney

Recruiting

Boise, Idaho, United States, 83706

NANI Research

Recruiting

Hinsdale, Illinois, United States, 60521

Northwest Louisiana Nephrology, LLC - Shreveport

Recruiting

Shreveport, Louisiana, United States, 71101

DaVita Clinical Research Edina

Recruiting

Edina, Minnesota, United States, 55435

St. Clair Nephrology Research

Recruiting

Roseville, Missouri, United States, 48066

Kidney Specialists of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89107

NYU Medical Center

Recruiting

New York, New York, United States, 10016-9196

Carolina Nephrology Greenville

Recruiting

Greenville, South Carolina, United States, 29605

Carolina Nephrology, PA

Recruiting

Spartanburg, South Carolina, United States, 29306

El Paso Kidney Specialists

Recruiting

El Paso, Texas, United States, 79902

Provecta Research Network

Recruiting

Houston, Texas, United States, 77027

DaVita Clinical Research Houston

Recruiting

Houston, Texas, United States, 77054

Davita Clinical Research San Antonio

Recruiting

San Antonio, Texas, United States, 78251

Utah Kidney Research

Recruiting

Salt Lake City, Utah, United States, 84115

Milwaukee Neprologists, SC

Recruiting

Wauwatosa, Wisconsin, United States, 53226

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-09-02.