Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
NCT ID: NCT04572854
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
13 participants
INTERVENTIONAL
2021-09-07
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study.
Pegcetacoplan
Complement (C3) Inhibitor
Group 2
No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment.
Pegcetacoplan
Complement (C3) Inhibitor
Interventions
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Pegcetacoplan
Complement (C3) Inhibitor
Eligibility Criteria
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Inclusion Criteria
* Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN
* Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
* eGFR ≥15 mL/min/1.73 m2, calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
* No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy
* Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization
* Have received required vaccinations against N. meningitidis, S. pneumoniae, and H. influenzae (type B) or agree to receive vaccinations, if applicable vaccination records are not available. Vaccination is mandatory unless documented evidence exists that subjects are non-responders to vaccination.
Exclusion Criteria
* Previous treatment with pegcetacoplan
* Evidence of rejection on the screening renal allograft biopsy that requires treatment
* Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection with any of these viruses
* Weight more than 100 kg at screening
* Hypersensitivity to pegcetacoplan or any of the excipients
* History of meningococcal disease
* Malignancy, except for the following:
* Cured basal or squamous cell skin cancer
* Curatively treated in situ disease
* Malignancy free and off treatment for ≥5 years
* Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection, or a medication) that would, in the opinion of the investigator, confound interpretation of the study results
* Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening
* Known or suspected hereditary fructose intolerance.
18 Years
ALL
No
Sponsors
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Apellis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Keck School of Medicine, University of Southern California
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University, St.Louis
St Louis, Missouri, United States
NYU Langone Health Transplant Insitute
New York, New York, United States
CUIMC
New York, New York, United States
Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner
San Juan Bautista, Buenos Aires, Argentina
Hospital Universitario Fundacion Favaloro
Buenos Aires, , Argentina
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Monash Medical Centre
Clayton, , Australia
Medical University of Vienna
Vienna, , Austria
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Botucatu, São Paulo, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, , Brazil
Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology
Lille, , France
Hopital Edouard Herriot, Hospices Civils de Lyon
Lyon, , France
Center Hospitalier Universitaire de Montpellier
Montpellier, , France
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Ranica, , Italy
Radbound University Medical Center
Nijmegen, , Netherlands
Hospital Universitario 12 de Octubre, Nephrology Department
Madrid, , Spain
CHUV
Lausanne, , Switzerland
Imperial College Healthcare NHS Trust
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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APL2-C3G-204
Identifier Type: -
Identifier Source: org_study_id
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