A 2-year, single-arm, multi-center study to explore the efficacy and safety of pegcetacoplan in preventing disease recurrence in adolescent and adult kidney transplant recipients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis

Condition studied

Male or female patients with a diagnosis of C3G or primary IC˗MPGN and planning to undergo kidney transplantation because of the disease.

Investigational medicinal product(s)

Every trial of Pegcetacoplan across our registers →

Eligibility

Primary endpoint

Occurrence of clinically significant recurrent disease within 2 years post–kidney transplantation, defined by both histological evidence from the biopsy and clinical evidence of recurrence (≥1 of the following: increase in urinary protein-to-creatinine ratio, decrease in eGFR, or hematuria), judged clinically significant by the Investigator in the absence of alternative causes

Endpoint detail

Time from kidney transplantation surgery to onset of clinically significant recurrence of C3G or primary IC-MPGN, Histological evidence of recurrent disease within 2 years of kidney transplantation, based on the histopathological assessment of a kidney biopsy at the study center, Time from kidney transplantation surgery to histological evidence of recurrent disease, The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)