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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521661-27-00 | Other Identifier | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Zai Lab (Shanghai) Co., Ltd. (for China only) | UNKNOWN |
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2b: Povetacicept | Experimental | Participants will be randomized to receive one of the two doses of Povetacicept. |
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| Phase 3: Povetacicept | Experimental | Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b). |
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| Phase 3: Calcineurin Inhibitor (CNI) | Active Comparator | Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povetacicept | Drug | Solution for Subcutaneous Injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) | At Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Complete Clinical Remission Definition 2 (CR2) | At Week 104 | |
| Proportion of Participants with Overall Clinical Remission (OR) | At Week 104 | |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Contact | 001-617-341-6777 | medicalinfo@vrtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal Associates | Recruiting | Montgomery | Alabama | 36117 | United States | |
| Southwest Kidney Institute, PLC (SKI) - Surprise |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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| Tacrolimus | Drug | Capsules for Oral Administration. |
|
| Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) |
| From Day 1 up to Week 112 |
| Recruiting |
| Surprise |
| Arizona |
| 85374 |
| United States |
| Academic Medical Research Institute (AMRI) | Recruiting | Los Angeles | California | 90022 | United States |
| Valiance Clinical Research - Internal Medicine | Recruiting | Tarzana | California | 91356 | United States |
| Western Nephrology & Metabolic Bone Disease PC | Recruiting | Arvada | Colorado | 80002 | United States |
| Bioresearch Partner | Recruiting | Miami | Florida | 33127 | United States |
| CTR Oakwater, LLC | Recruiting | Orlando | Florida | 32806 | United States |
| Clinical Site Partners, LLC - Orlando | Recruiting | Winter Park | Florida | 32789 | United States |
| DaVita Clinical Research Columbus | Recruiting | Columbus | Georgia | 31904 | United States |
| Georgia Nephrology | Recruiting | Lawrenceville | Georgia | 30046 | United States |
| CARE Institute-Boise Kidney | Recruiting | Boise | Idaho | 83706 | United States |
| NANI Research | Recruiting | Hinsdale | Illinois | 60521 | United States |
| DaVita Clinical Research Edina | Recruiting | Edina | Minnesota | 55435 | United States |
| Kidney Specialists of Southern Nevada | Recruiting | Las Vegas | Nevada | 89107 | United States |
| Carolina Nephrology Greenville | Recruiting | Greenville | South Carolina | 29605 | United States |
| Carolina Nephrology, PA | Recruiting | Spartanburg | South Carolina | 29306 | United States |
| El Paso Kidney Specialists | Recruiting | El Paso | Texas | 79902 | United States |
| Provecta Research Network | Recruiting | Houston | Texas | 77027 | United States |
| DaVita Clinical Research Houston | Recruiting | Houston | Texas | 77054 | United States |
| Davita Clinical Research San Antonio | Recruiting | San Antonio | Texas | 78251 | United States |
| Utah Kidney Research | Recruiting | Salt Lake City | Utah | 84115 | United States |
| Milwaukee Neprologists, SC | Recruiting | Wauwatosa | Wisconsin | 53226 | United States |
| Monash Medical Centre | Recruiting | Clayton | Australia |
| Concord Repatriation General Hospital | Recruiting | Concord | Australia |
| St George Private Hospital | Recruiting | Kogarah | Australia |
| University of Newcastle - John Hunter Hospital (JHH) | Recruiting | New Lambton Heights | Australia |
| Freire Pesquisa Clinica | Recruiting | Belo Horizonte | Brazil |
| Santa Casa de Misericordia | Recruiting | Porto Alegre | Brazil |
| Universidade Federal de Pernmabuco | Recruiting | Recife | Brazil |
| Fundação Bahiana de Infectologia | Recruiting | Salvador | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP | Recruiting | São Paulo | Brazil |
| The First Affiliated Hospital of Baotou Medical College | Recruiting | Baotou | China |
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | China |
| Peking University First Hospital | Recruiting | Beijing | China |
| The First Affiliated Hospital of Bengbu Medical University | Recruiting | Bengbu | China |
| The Second Norman Bethune Hospital of Jilin University | Recruiting | Changchun | China |
| Xiangya Hospital of Central South University | Recruiting | Changsha | China |
| Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital | Recruiting | Chengdu | China |
| Dalian Municipal Central Hospital | Recruiting | Dalian | China |
| Dongguan People's Hospital | Recruiting | Dongguan | China |
| Fuyang People's Hospital | Recruiting | Fuyang | China |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | China |
| The First Affiliated Hospital,Sun Yat-sen University | Recruiting | Guangzhou | China |
| The 2nd Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | China |
| The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University | Recruiting | Huai'an | China |
| The Second Qilu Hospital of Shandong University | Recruiting | Jinan | China |
| Liu Zhou Works Hospital | Recruiting | Liuzhou | China |
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | China |
| Nanyang Central Hospital | Recruiting | Nanyang | China |
| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | China |
| Shanghai General Hospital | Recruiting | Shanghai | China |
| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
| The Fourth Hospital of Hebei Medical Univesrsity | Recruiting | Shijiazhuang | China |
| The Second Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
| Tai'an City Central Hosptial | Recruiting | Tai’an | China |
| Weifang People's Hospital | Recruiting | Weifang | China |
| Wuxi People's Hospital | Recruiting | Wuxi | China |
| The First Affiliated Hospital of Xi 'an Jiaotong University | Recruiting | Xi'an | China |
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | China |
| Yantai YuHuangDing Hospital | Recruiting | Yantai | China |
| Yichang Central People Hospital | Recruiting | Yichang | China |
| Vseobecna fakultni nemocnice v Praze - Klinika nefrologie | Recruiting | Prague | Czechia |
| Charite - Universitaetsmedizin Berlin Campus Benjamin Frankl | Recruiting | Allemagne | Germany |
| Klinikum St. Georg gGmbH - Nephrology | Recruiting | Leipzig | Germany |
| Universitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Poliklinik fuer Endokrinologie, Nephrologie | Recruiting | Leipzig | Germany |
| Universitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie | Recruiting | Würzburg | Germany |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Recruiting | Szeged | Hungary |
| Beaumont Hospital | Recruiting | Dublin | Ireland |
| St. Vincent'S University Hospital | Recruiting | Dublin | Ireland |
| University Hospital Galway | Recruiting | Galway | Ireland |
| AOU Consorziale Policlinico di Bari - Nefrologia, Dialisi e Trapianti | Recruiting | Bari | Italy |
| IRCCS Ospedale Policlinico San Martino | Recruiting | Genova | Italy |
| Azienda Ospedaliera Universitaria Federico II | Recruiting | Naples | Italy |
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | Italy |
| Fondazione Salvatore Maugeri - Nefrologia e Dialisi | Recruiting | Pavia | Italy |
| Kanazawa University Hospital | Recruiting | Kanazawa | Japan |
| Kasugai Municipal Hospital | Recruiting | Kasugai | Japan |
| Okayama University Hospital | Recruiting | Okayama | Japan |
| Nagoya University Hospital | Recruiting | Shōwaku | Japan |
| The University of Osaka Hospital | Recruiting | Suita | Japan |
| Fujita Health University | Recruiting | Toyoake-Shi | Japan |
| Juntendo University Urayasu Hospital | Recruiting | Urayasu | Japan |
| Hallym University Sacred Heart Hospital | Recruiting | Anyang-si | South Korea |
| Korea University Anam Hospital - Nephrology | Recruiting | Seoul | South Korea |
| Kyung Hee University Hospital at Gangdong - Nephrology | Recruiting | Seoul | South Korea |
| Samsung Medical Center - Nephrology | Recruiting | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System - Nephrology | Recruiting | Seoul | South Korea |
| Yongin Severance Hospital - Nephrology | Recruiting | Yongin-si | South Korea |
| Hospital Universitari Vall D Hebron | Recruiting | Barcelona | Spain |
| Hospital Universitario Reina Sofia | Recruiting | Córdoba | Spain |
| Hospital Ribera Polusa | Recruiting | Lugo | Spain |
| Clinica Universidad de Navarra - Nefrología | Recruiting | Pamplona | Spain |
| Hospital Universitario Virgen de la Macarena - Nefrología | Recruiting | Seville | Spain |
| University Hospital of Derby and Burton NHS Foundation Trust - Royal Derby Hospital | Recruiting | Derby | United Kingdom |
| Doncaster and Bassetlaw Hospitals NHS Foundation Trust - Doncaster Royal Infirmary | Recruiting | Doncaster | United Kingdom |
| NHS Lothian - Royal Infirmary of Edinburgh | Recruiting | Edinburgh | United Kingdom |
| Imperial College Healthcare NHS Trust - Hammersmith Hospital | Recruiting | London | United Kingdom |
| St George's University Hospitals NHS Foundation Trust - St George's Hospital- Renal Medicine | Recruiting | London | United Kingdom |
| The Royal Wolverhampton NHS Trust - New Cross Hospital | Recruiting | Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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