Research Project

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

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