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Clinical Trials in Czechia / NCT05809531
Active, not recruiting Phase 3

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

NCT05809531 · tracked via the Priya Life Science Czechia tracker
Phase
Phase 3
Started
2023-05-29
Last updated
2026-04-02

Condition(s) studied

C3GIC-MPGNC3 GlomerulopathyC3 GlomerulonephritisComplement 3 GlomerulopathyComplement 3 Glomerulopathy (C3G)Complement 3 GlomerulonephritisDense Deposit DiseaseDDDMembranoproliferative GlomerulonephritisMembranoproliferative Glomerulonephritis (MPGN)Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

Investigational drug(s) / intervention(s)

Pegcetacoplan →

Pegcetacoplan: Complement (C3) Inhibitor

Study summary

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)

Trial sites (47)

FacilityCityRegionStatus
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.

More Apellis Pharmaceuticals, Inc. trials in Czechia

Other trials for the same condition

Official registry record

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.

View NCT05809531 on ClinicalTrials.gov ↗ ← All trials in Czechia