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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504625-39-00 | Other Identifier | CTIS | |
| U1111-1290-7826 | Other Identifier | Universal Trial Number (UTN) | |
| 2022-002833-33 | EudraCT Number |
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This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegcetacoplan administered subcutaneously | Experimental | Pegcetacoplan administered subcutaneously twice weekly according to protocol defined dosing regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegcetacoplan | Drug | Complement (C3) Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time. | 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Research Institute (01034) | Los Angeles | California | 90022 | United States | ||
| Children's Hospital Colorado (01037) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42133432 | Derived | Vivarelli M, Ariceta G, Borovitz Y, Dixon BP, Greenbaum LA, Licht C, Mastrangelo A, Melhem N, Fujita N, van de Kar NCAJ, Wallace D, Khankin E, Wang Z, Lopez-Lazaro L, Szamosi J, Nester CM. Pegcetacoplan for Adolescents with C3 Glomerulopathy or Primary Immune Complex Membranoproliferative GN: Phase 3 VALIANT Subgroup Analysis. Clin J Am Soc Nephrol. 2026 May 14. doi: 10.2215/CJN.0000001077. Online ahead of print. |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Florida, Department of Pediatric Nephrology (01010) | Gainsville | Florida | 32610 | United States |
| Emory Investigational Drug Service (01021) | Atlanta | Georgia | 30322 | United States |
| University of Iowa Hospital and Clinics (01030) | Iowa City | Iowa | 52242 | United States |
| University of Michigan Hospital (01008) | Ann Arbor | Michigan | 48109 | United States |
| Hackensack Meridian Health (01036) | Hackensack | New Jersey | 07601 | United States |
| Cohen Children Hospital, Pediatric Pharmacy (01022) | Hyde Park | New York | 11040 | United States |
| Columbia Nephrology (01039) | New York | New York | 10032 | United States |
| Oregon Health & Science Univ., Dept. Pediatrics (01038) | Portland | Oregon | 97239 | United States |
| Northeast Clinical Research Center LLC (01009) | Bethlehem | Pennsylvania | 18017 | United States |
| Texas Children's Hospital (01027) | Houston | Texas | 77030 | United States |
| Hospital Privado-Universitario de Cordoba (54004) | Córdoba | CPA X5016KEH | Argentina |
| Clinica Privada Velez Sarsfield (54007) | Córdoba | X5000 | Argentina |
| Kidney Trials Unit, Princess Alexandra Hospital (61007) | Woolloongab | Queensland | 4102 | Australia |
| St. Vincent's Hospital Melbourne (61003) | Fitzroy | 3065 | Australia |
| Catholic University of Leuven (32001) | Leuven | B-3000 | Belgium |
| Santa Casa de Misericordia de Belo Horizonte (55017) | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Irmandade da Santa Casa Misericordia Porto Alegre (55016) | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| HC UNESP Botucatu (55010) | Botucatu | 18618-687 | Brazil |
| Hospital de Clinicas de Porto Alegre (55018) | Porto Alegre | 90035-903 | Brazil |
| Real Hospital Portugues de Beneficencia (55015) | Recife | 52010-095 | Brazil |
| Ruschel Medicina E Pesquisa Clinica (55012) | Rio de Janeiro | 22270-060 | Brazil |
| Hospital De Base (55014) | São José do Rio Preto | 1500900-000 | Brazil |
| Hospital do Rim - Fundacao Oswaldo Ramos (55005) | São Paulo | 04038-002 | Brazil |
| Univ Sao Paulo, Av. Dr Eneas Carvalho de Aguiar, 155 (55007) | São Paulo | 05403-900 | Brazil |
| Institute for Clinical and Experimental Medicine (42001) | Prague | 14021 | Czechia |
| CHU de Bordeaux - Hopital Pellegrin (33010) | Bordeaux | 33076 | France |
| Institut de transplantation urologie-nephrologie (33011) | Nantes | 44093 | France |
| Schneider Childrens Medical Center (97204) | Petah Tikva | 4920235 | Israel |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (39004) | Milan | 20122 | Italy |
| Istituto di Ricerche Farmacologiche Mario Negri IRCCS (39003) | Ranica | 24020 | Italy |
| Ospesale Pediatrico bambino Gesu (39005) | Rome | 165 | Italy |
| Nagasaki University Hospital (81005) | Nagasaki | Nagasaki | 852-8501 | Japan |
| Seirei Hamamatsu General Hospital (81004) | Hamamatsu | Shizuoka | 430-8558 | Japan |
| AMC Apotheek Goederenontvangst (31002) | Amsterdam | 1105 AZ | Netherlands |
| University Medical Center Groningen (31004) | Groningen de Brug | 9713 GZ | Netherlands |
| Radboud University Medical Center (31003) | Nijmegen | 6500 HB | Netherlands |
| Yonsei University College of Medicine, Sinchon Severance Hospital (82002) | Seoul | 3722 | South Korea |
| Seoul National University Hospital (82003 & 82005) | Soeul | 3080 | South Korea |
| Hosp. Universit. Materno-Infantil Vall d' Hebron (34006) | Barcelona | 8035 | Spain |
| Hospital Universitario 12 de Octubre (34008) | Madrid | 28041 | Spain |
| Hospital Universitario Dr Peset (34009) | Valencia | 46017 | Spain |
| CHUV Lausanne (41002) | Lausanne | CH-1011 | Switzerland |
| Imperial College Hammersmith Hospital (44013) | London | W12 0HS | United Kingdom |
| Royal Manchester Children's Hospital (44011) | Manchester | M13 9WL | United Kingdom |
| Nottingham University Hospitals NHS Trust (44012) | Nottingham | NG7 2UH | United Kingdom |
| ID | Term |
|---|---|
| D015432 | Glomerulonephritis, Membranoproliferative |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000716074 | pegcetacoplan |
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