Research Project

Project Title:	APPEAR C3 G
Project Type:	Clinical Trial, Enrolment ongoing Adjunct biobank: Serum, Plasma, Urine
Disease group(s):	Immune glomerulopathies
Project Summary:	The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to placebo and standard of care in patients with native C3G. CLNP023B12301 is a Phase 3 pivotal trial for registration of iptacopan in C3G. The study aims to determine the reduction in UPCR and improvement in eGFR in participants treated with iptacopan compared to placebo, as well as the proportion of participants who achieve a composite renal endpoint consisting of eGFR and UPCR elements. These effects of iptacopan in conjunction with increases in serum C3 levels will provide support for an iptacopan profile that includes stabilization of eGFR, clinically meaningful reductions in proteinuria and inhibition of the complement AP. Kidney biopsies will be performed in all participants to evaluate histopathological improvements in immunofluorescence and light microscopy that support these functional benefits of iptacopan.
Lead principal investigator(s):	Giuseppe Remuzzi, Bergamo
Co-investigator(s):	Erica Daina, Milao Amantia Imeraj, Milano
Project Period:	07/2021 - 08/2023
Sponsors:	Industry
ClinicalTrials.gov:	NCT04817618