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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Other protocol defined Inclusion/Exclusion criteria will apply

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2b: Povetacicept 		Participants will be randomized to receive one of the two doses of Povetacicept.
  • Drug: Povetacicept
    Solution for Subcutaneous Injection.
Experimental
Phase 3: Povetacicept 		Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b).
  • Drug: Povetacicept
    Solution for Subcutaneous Injection.
Active Comparator
Phase 3: Calcineurin Inhibitor (CNI) 		Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.
  • Drug: Tacrolimus
    Capsules for Oral Administration.

Recruiting Locations

Renal Associates
Montgomery, Alabama 36117

Southwest Kidney Institute, PLC (SKI) - Surprise
Surprise, Arizona 85374

Academic Medical Research Institute (AMRI)
Los Angeles, California 90022

Valiance Clinical Research - Internal Medicine
Tarzana, California 91356

Western Nephrology & Metabolic Bone Disease PC
Arvada, Colorado 80002

Bioresearch Partner
Miami, Florida 33127

CTR Oakwater, LLC
Orlando, Florida 32806

Clinical Site Partners, LLC - Orlando
Winter Park, Florida 32789

DaVita Clinical Research Columbus
Columbus, Georgia 31904

Georgia Nephrology
Lawrenceville, Georgia 30046

CARE Institute-Boise Kidney
Boise, Idaho 83706

NANI Research
Hinsdale, Illinois 60521

DaVita Clinical Research Edina
Edina, Minnesota 55435

Kidney Specialists of Southern Nevada
Las Vegas, Nevada 89107

Carolina Nephrology Greenville
Greenville, South Carolina 29605

Carolina Nephrology, PA
Spartanburg, South Carolina 29306

El Paso Kidney Specialists
El Paso, Texas 79902

Provecta Research Network
Houston, Texas 77027

DaVita Clinical Research Houston
Houston, Texas 77054

Davita Clinical Research San Antonio
San Antonio, Texas 78251

Utah Kidney Research
Salt Lake City, Utah 84115

Milwaukee Neprologists, SC
Wauwatosa, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.