An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
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).
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Completed participation in Study APL2-C3G-310 through the week 52 visit requirements
* Experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator
* Must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2-C3G-310
* Received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) according to the requirements of Study APL2-C3G-310 and agree to receive any additional vaccinations recommended according to ACIP recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines
* Female participants of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have a negative urine pregnancy test at visit 1 and must agree to use protocol-defined methods of contraception for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
* Male participants must agree to use protocol-defined methods of contraception and agree to refrain from donating semen for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
* Participants above the legal age of consent, in accordance with local regulations, must be willing and able to provide informed consent. The legally authorized representative of participants under the legal age of consent must be willing and able to provide informed consent; where appropriate, participants under the legal age of consent must also give their assent to participation in the study
* Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration
Exclusion Criteria:
* Female participants who are or are planning to become pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug
* Inability or unwillingness to cooperate with the requirements of the protocol
* Any condition that, in the opinion of the investigator, creates an undue risk for the participant by participating in the study or is likely to confound interpretation of the study results
* Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator
Primary outcome measure(s)
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
Trial sites (47)
Facility
City
Region
Status
Academic Medical Research Institute (01034)
Los Angeles
California
Children's Hospital Colorado (01037)
Aurora
Colorado
University of Florida, Department of Pediatric Nephrology (01010)
Gainsville
Florida
Emory Investigational Drug Service (01021)
Atlanta
Georgia
University of Iowa Hospital and Clinics (01030)
Iowa City
Iowa
University of Michigan Hospital (01008)
Ann Arbor
Michigan
Hackensack Meridian Health (01036)
Hackensack
New Jersey
Cohen Children Hospital, Pediatric Pharmacy (01022)
Hyde Park
New York
Columbia Nephrology (01039)
New York
New York
Oregon Health & Science Univ., Dept. Pediatrics (01038)
Portland
Oregon
Northeast Clinical Research Center LLC (01009)
Bethlehem
Pennsylvania
Texas Children's Hospital (01027)
Houston
Texas
Hospital Privado-Universitario de Cordoba (54004)
Córdoba
Argentina
Clinica Privada Velez Sarsfield (54007)
Córdoba
Argentina
Kidney Trials Unit, Princess Alexandra Hospital (61007)
Woolloongab
Queensland
St. Vincent's Hospital Melbourne (61003)
Fitzroy
Australia
Catholic University of Leuven (32001)
Leuven
Belgium
Santa Casa de Misericordia de Belo Horizonte (55017)
Belo Horizonte
Minas Gerais
Irmandade da Santa Casa Misericordia Porto Alegre (55016)
Porto Alegre
Rio Grande do Sul
HC UNESP Botucatu (55010)
Botucatu
Brazil
Hospital de Clinicas de Porto Alegre (55018)
Porto Alegre
Brazil
Real Hospital Portugues de Beneficencia (55015)
Recife
Brazil
Ruschel Medicina E Pesquisa Clinica (55012)
Rio de Janeiro
Brazil
Hospital De Base (55014)
São José do Rio Preto
Brazil
Hospital do Rim - Fundacao Oswaldo Ramos (55005)
São Paulo
Brazil
Univ Sao Paulo, Av. Dr Eneas Carvalho de Aguiar, 155 (55007)
São Paulo
Brazil
Institute for Clinical and Experimental Medicine (42001)
Prague
Czechia
CHU de Bordeaux - Hopital Pellegrin (33010)
Bordeaux
France
Institut de transplantation urologie-nephrologie (33011)
Nantes
France
Schneider Childrens Medical Center (97204)
Petah Tikva
Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (39004)
Milan
Italy
Istituto di Ricerche Farmacologiche Mario Negri IRCCS (39003)
Ranica
Italy
Ospesale Pediatrico bambino Gesu (39005)
Rome
Italy
Nagasaki University Hospital (81005)
Nagasaki
Nagasaki
Seirei Hamamatsu General Hospital (81004)
Hamamatsu
Shizuoka
AMC Apotheek Goederenontvangst (31002)
Amsterdam
Netherlands
University Medical Center Groningen (31004)
Groningen de Brug
Netherlands
Radboud University Medical Center (31003)
Nijmegen
Netherlands
Yonsei University College of Medicine, Sinchon Severance Hospital (82002)
Seoul
South Korea
Seoul National University Hospital (82003 & 82005)
Soeul
South Korea
+ 7 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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