Étude de phase 2 en ouvert, randomisée et contrôlée évaluant la sécurité d’emploi et l’efficacité du Pegcetacoplan pour le traitement de la récurrence post-transplantation des glomérulopathies à dépôt de C3 (GP-C3) ou des glomérulonéphrites membranoprolifératives à complexes immuns (GNMP-CI)

Drug: Pegcetacoplan

Inclusion Criteria: - Patients of at least 18 years of age at screening - Patients must have clinical and pathologic evidence of recurrent C3G or IC-MPGN, as evidenced by all of the following: - Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan - eGFR =30 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 - Willing to receive vaccinations against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae if applicable vaccination records are not available 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 - 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 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
Minimum age: 18 Years
Maximum age: N/A
Sex: All