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

Part of paid clinical trials in Montgomery, Alabama.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT07204275
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Primary Membranous Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Povetacicept — DRUG
    Solution for Subcutaneous Injection.
  • Tacrolimus — DRUG
    Capsules for Oral Administration.

Study Details

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

Key Dates

Start date
Sep 30, 2025
Status verified
Jun 2026
Primary completion
Dec 29, 2028
Completion
Dec 29, 2028

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Renal AssociatesMontgomeryAlabama36117-
Southwest Kidney Institute, PLC (SKI) - SurpriseSurpriseArizona85374-
Academic Medical Research Institute (AMRI)Los AngelesCalifornia90022-
Valiance Clinical Research - Internal MedicineTarzanaCalifornia91356-
Western Nephrology & Metabolic Bone Disease PCArvadaColorado80002-
Bioresearch PartnerMiamiFlorida33127-
CTR Oakwater, LLCOrlandoFlorida32806-
Clinical Site Partners, LLC - OrlandoWinter ParkFlorida32789-
DaVita Clinical Research ColumbusColumbusGeorgia31904-
Georgia NephrologyLawrencevilleGeorgia30046-
CARE Institute-Boise KidneyBoiseIdaho83706-
NANI ResearchHinsdaleIllinois60521-
DaVita Clinical Research EdinaEdinaMinnesota55435-
Kidney Specialists of Southern NevadaLas VegasNevada89107-
Carolina Nephrology GreenvilleGreenvilleSouth Carolina29605-
Carolina Nephrology, PASpartanburgSouth Carolina29306-
El Paso Kidney SpecialistsEl PasoTexas79902-
DaVita Clinical Research HoustonHoustonTexas77054-
Provecta Research NetworkHoustonTexas77027-
Davita Clinical Research San AntonioSan AntonioTexas78251-
Utah Kidney ResearchSalt Lake CityUtah84115-
Milwaukee Neprologists, SCWauwatosaWisconsin53226-

Find similar trials in Montgomery, AL

By research site
Renal Associates· Montgomery, ALSouthwest Kidney Institute, PLC (SKI) - Surprise· Surprise, AZAcademic Medical Research Institute (AMRI)· Los Angeles, CAValiance Clinical Research - Internal Medicine· Tarzana, CAWestern Nephrology & Metabolic Bone Disease PC· Arvada, COBioresearch Partner· Miami, FL

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