Research Project

Project Title:	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
Project Type:	Clinical Trial, Enrolment ongoing Adjunct biobank: Serum, Plasma, Urine
Disease group(s):	Immune glomerulopathies
Project Summary:	This is an open-label, single-arm, multicenter study to evaluate the long-term safety and efficacy of twice-weekly subcutaneous infusions of pegcetacoplan in patients with C3G or IC-MPGN who have completed participation in Study APL2-C3G-310 and who, in the opinion of the investigator, have experienced clinical benefit from pegcetacoplan administration. Participants will be enrolled in this study for a minimum of 120 weeks (approximately 2.5 years) and may continue to receive treatment with pegcetacoplan until it is commercially available for treatment of C3G and/or IC-MPGN or the development program for C3G and/or IC-MPGN is terminated.
Lead principal investigator(s):	Giovanni Montini, Milan
Co-investigator(s):	Antonio Mastrangelo, Milan
Project Period:	01/2024 - 01/2050
Sponsors:	Industry
Project web page:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002833-33/CZ
EudraCT Nr.:	2022-002833-33