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
NCT ID: NCT05809531
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2023-05-29
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pegcetacoplan administered subcutaneously
Pegcetacoplan administered subcutaneously twice weekly according to protocol defined dosing regimen
Pegcetacoplan
Complement (C3) Inhibitor
Interventions
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Pegcetacoplan
Complement (C3) Inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Apellis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Academic Medical Research Institute (01034)
Los Angeles, California, United States
Children's Hospital Colorado (01037)
Aurora, Colorado, United States
University of Florida, Department of Pediatric Nephrology (01010)
Gainesville, Florida, United States
Emory Investigational Drug Service (01021)
Atlanta, Georgia, United States
University of Iowa Hospital and Clinics (01030)
Iowa City, Iowa, United States
University of Michigan Hospital (01008)
Ann Arbor, Michigan, United States
Hackensack Meridian Health (01036)
Hackensack, New Jersey, United States
Cohen Children Hospital, Pediatric Pharmacy (01022)
Hyde Park, New York, United States
Columbia Nephrology (01039)
New York, New York, United States
Oregon Health & Science Univ., Dept. Pediatrics (01038)
Portland, Oregon, United States
Northeast Clinical Research Center LLC (01009)
Bethlehem, Pennsylvania, United States
Texas Children's Hospital (01027)
Houston, Texas, United States
Hospital Privado-Universitario de Cordoba (54004)
Córdoba, , Argentina
Clinica Privada Velez Sarsfield (54007)
Córdoba, , Argentina
Kidney Trials Unit, Princess Alexandra Hospital (61007)
Woolloongab, Queensland, Australia
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, Brazil
Irmandade da Santa Casa Misericordia Porto Alegre (55016)
Porto Alegre, Rio Grande do Sul, Brazil
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, Japan
Seirei Hamamatsu General Hospital (81004)
Hamamatsu, Shizuoka, Japan
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
Hosp. Universit. Materno-Infantil Vall d' Hebron (34006)
Barcelona, , Spain
Hospital Universitario 12 de Octubre (34008)
Madrid, , Spain
Hospital Universitario Dr Peset (34009)
Valencia, , Spain
CHUV Lausanne (41002)
Lausanne, , Switzerland
Imperial College Hammersmith Hospital (44013)
London, , United Kingdom
Royal Manchester Children's Hospital (44011)
Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust (44012)
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2023-504625-39-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1290-7826
Identifier Type: OTHER
Identifier Source: secondary_id
2022-002833-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APL2-C3G-314
Identifier Type: -
Identifier Source: org_study_id
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