Project Title: |
A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN PATIENTS WITH C3 GLOMERULOPATHY OR IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS |
Project Type: |
Clinical Trial, Enrolment terminated Adjunct biobank: Serum, Plasma, Urine |
Disease group(s): |
Immune glomerulopathies |
Project Summary: |
This is a placebo-controlled, double-blinded, phase 3 study in patients with clinical and pathologic evidence of primary C3G or IC-MPGN. Participants will be randomly assigned 1:1 to either the pegcetacoplan group (pegcetacoplan treatment throughout the RCP and open-label period) or the placebo group (placebo treatment during the RCP and pegcetacoplan treatment during the open-label period). |
Lead principal investigator(s): |
Giovanni Montini, Milan |
Co-investigator(s): |
Antonio Mastrangelo, Milan |
Project Period: |
07/2022 - 07/2050 |
Sponsors: |
Industry |
Project web page: |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003767-25/ES |
EudraCT Nr.: |
2020-003767-25 |