Study detail
RecruitingPhase 2
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
Vertex Pharmaceuticals Incorporated
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
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
Interventions
- DrugPovetacicept
Solution for Subcutaneous Injection.
- DrugTacrolimus
Capsules for Oral Administration.
Locations (86)
- Renal AssociatesMontgomery, Alabama
- Southwest Kidney Institute, PLC (SKI) - SurpriseSurprise, Arizona
- Academic Medical Research Institute (AMRI)Los Angeles, California
- Valiance Clinical Research - Internal MedicineTarzana, California
- Western Nephrology & Metabolic Bone Disease PCArvada, Colorado
- Bioresearch PartnerMiami, Florida