Research Project

Project Title:	A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IgAN)
Project Type:	Clinical Trial, Enrolment ongoing
Disease group(s):	Immune glomerulopathies
Project Summary:	This is a multi-part study comprising of the original Phase 2b study (active, no longer recruiting) and the addition of a separate pivotal Phase 3 study (active, recruiting). After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study (active, recruiting) will evaluate the efficacy and safety of atacicept compared to placebo in reducing proteinuria in subjects with IgAN and persistent proteinuria despite being on a maximally tolerated dose (MTD) of a RASi. Safety, eGFR, serum immunoglobulins and Gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 104wk double-blind treatment period, followed by a 52wk open-label treatment period and a 26wk safety follow-up period. The UPCR primary endpoint will be assessed after the first 200 patients are randomized.
Lead principal investigator(s):	Smaragdi Marinaki, Athens
Co-investigator(s):	Ioannis Boletis, Athens Eleni Kapsia, Athens
Project Period:	05/2023 - 07/2028