Povetacicept for people with primary membranous nephropathy
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
PHASE2; PHASE3 · Vertex Pharmaceuticals Incorporated · NCT07204275
This trial tests whether povetacicept is safe and helps people with primary membranous nephropathy, with tacrolimus listed as an intervention in the protocol.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated (industry) |
| Locations | 93 sites (Montgomery, Alabama and 92 other locations) |
| Trial ID | NCT07204275 on ClinicalTrials.gov |
What this trial studies
This Phase 2/3 interventional trial tests the efficacy, safety, and tolerability of povetacicept in adults with biopsy‑confirmed primary membranous nephropathy. Participants must have a historical confirming biopsy or agree to a biopsy during screening, and the protocol also includes tacrolimus as a listed intervention. The study will track clinical endpoints related to disease activity and adverse events over the treatment and follow‑up periods. Vertex Pharmaceuticals is the lead sponsor and the trial is being conducted at selected US renal centers.
Who should consider this trial
Good fit: Adults with biopsy‑confirmed primary membranous nephropathy, or those willing to undergo a screening biopsy, who meet the protocol’s other eligibility criteria and have no hypersensitivity to the study drugs are the expected candidates.
Not a fit: Patients with secondary membranous nephropathy, known hypersensitivity to the investigational product or its excipients, or other exclusionary medical conditions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, povetacicept could reduce proteinuria and lower the risk of progressive kidney damage in people with primary membranous nephropathy.
How similar studies have performed: Other immunomodulatory treatments such as rituximab and calcineurin inhibitors like tacrolimus have shown benefit in pMN, while povetacicept represents a newer therapeutic approach still being tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montgomery, Alabama and 92 other locations
- Renal Associates — Montgomery, Alabama, United States (RECRUITING)
- Southwest Kidney Institute, PLC (SKI) - Surprise — Surprise, Arizona, United States (RECRUITING)
- Academic Medical Research Institute (AMRI) — Los Angeles, California, United States (RECRUITING)
- Valiance Clinical Research - Internal Medicine — Tarzana, California, United States (RECRUITING)
- Western Nephrology & Metabolic Bone Disease PC — Arvada, Colorado, United States (RECRUITING)
- Bioresearch Partner — Miami, Florida, United States (RECRUITING)
- CTR Oakwater, LLC — Orlando, Florida, United States (RECRUITING)
- Clinical Site Partners, LLC - Orlando — Winter Park, Florida, United States (RECRUITING)
- DaVita Clinical Research Columbus — Columbus, Georgia, United States (RECRUITING)
- Georgia Nephrology — Lawrenceville, Georgia, United States (RECRUITING)
- CARE Institute-Boise Kidney — Boise, Idaho, United States (RECRUITING)
- NANI Research — Hinsdale, Illinois, United States (RECRUITING)
- DaVita Clinical Research Edina — Edina, Minnesota, United States (RECRUITING)
- Kidney Specialists of Southern Nevada — Las Vegas, Nevada, United States (RECRUITING)
- Carolina Nephrology Greenville — Greenville, South Carolina, United States (RECRUITING)
- Carolina Nephrology, PA — Spartanburg, South Carolina, United States (RECRUITING)
- El Paso Kidney Specialists — El Paso, Texas, United States (RECRUITING)
- Provecta Research Network — Houston, Texas, United States (RECRUITING)
- DaVita Clinical Research Houston — Houston, Texas, United States (RECRUITING)
- Davita Clinical Research San Antonio — San Antonio, Texas, United States (RECRUITING)
- Utah Kidney Research — Salt Lake City, Utah, United States (RECRUITING)
- Milwaukee Neprologists, SC — Wauwatosa, Wisconsin, United States (RECRUITING)
- St George Private Hospital — Kogarah, Australia (RECRUITING)
- University of Newcastle - John Hunter Hospital (JHH) — New Lambton Heights, Australia (RECRUITING)
- Freire Pesquisa Clinica — Belo Horizonte, Brazil (RECRUITING)
- Santa Casa de Misericordia — Porto Alegre, Brazil (RECRUITING)
- Fundação Bahiana de Infectologia — Salvador, Brazil (RECRUITING)
- Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP — São Paulo, Brazil (RECRUITING)
- The First Affiliated Hospital of Baotou Medical College — Baotou, China (RECRUITING)
- Beijing Tsinghua Changgung Hospital — Beijing, China (RECRUITING)
- Peking University First Hospital — Beijing, China (RECRUITING)
- The First Affiliated Hospital of Bengbu Medical University — Bengbu, China (RECRUITING)
- The Second Norman Bethune Hospital of Jilin University — Changchun, China (RECRUITING)
- Xiangya Hospital of Central South University — Changsha, China (RECRUITING)
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital — Chengdu, China (RECRUITING)
- Dalian Municipal Central Hospital — Dalian, China (RECRUITING)
- Dongguan People's Hospital — Dongguan, China (RECRUITING)
- Fuyang People's Hospital — Fuyang, China (RECRUITING)
- Guangdong Provincial People's Hospital — Guangzhou, China (RECRUITING)
- The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, China (RECRUITING)
- The 2nd Affiliated Hospital of Harbin Medical University — Harbin, China (RECRUITING)
- The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University — Huai'an, China (RECRUITING)
- The Second Qilu Hospital of Shandong University — Jinan, China (RECRUITING)
- Liu Zhou Works Hospital — Liuzhou, China (RECRUITING)
- The First Affiliated Hospital of Nanchang University — Nanchang, China (RECRUITING)
- The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, China (RECRUITING)
- Nanyang Central Hospital — Nanyang, China (RECRUITING)
- The First Affiliated Hospital of Ningbo University — Ningbo, China (RECRUITING)
- Renji Hospital Shanghai Jiaotong University School of Medicine — Shanghai, China (RECRUITING)
- Shanghai General Hospital — Shanghai, China (RECRUITING)
+43 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Membranous Nephropathy