Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

Completed · Phase 2

Conditions studied: C3G, IC-MPGN, Renal Transplant, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Dense Deposit Disease (DDD), Membranoproliferative Glomerulonephritis, Membranoproliferative Glomerulonephritis (MPGN), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulonephritis

In brief

This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.

Key facts

Study ID

NCT04572854

Run by

Apellis Pharmaceuticals, Inc.

People needed

13

Starts

2021-09-07

Expected to finish

2026-01-20

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age at screening
• 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.

You may not qualify if…

• Absolute neutrophil count <1000 cells/mm3 during screening
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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