Research Project

Project Title:


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

Lead principal investigator(s):

Giuseppe Remuzzi, Bergamo


Erica Daina, Milao
Amantia Imeraj, Milano

Project Period:

07/2021   -   08/2023




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