POS-132 TRIAL DESIGN: PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF NARSOPLIMAB SAFETY AND EFFICACY IN IGA NEPHROPATHY (ARTEMIS-IGAN)

Kidney International Reports, vol. 7, pp. S57

Abstract

IgA nephropathy (IgAN) is a glomerular disease in which the lectin pathway of complement is activated by immune complex deposition on mesangial cells. Narsoplimab (OMS721) is a fully human IgG4 monoclonal antibody that inhibits mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway. Narsoplimab was evaluated for the treatment of IgAN in a Phase 2 clinical trial (NCT02682407) and an interim analysis suggested a substantial and clinically meaningful therapeutic effect (Lafayette RA, et al.

Authors 6

1. Richard A. Lafayette

   Stanford Medicine · Stanford University

   Affiliation as printed

   Stanford University, Division of Nephrology, Stanford, United States

2. Brad H. Rovin

   The Ohio State University Wexner Medical Center

   Affiliation as printed

   The Ohio State University Wexner Medical Center, Division of Nephrology, Columbus, United States

3. Jürgen Floege Aachen Division of Nephrology and Immunology

   Universitätsklinikum Aachen · RWTH Aachen University

   Affiliation as printed

   RWTH Aachen University Hospital, Division of Nephrology and Immunology, Aachen, Germany

4. Vladimı́r Tesař

   Charles University

   Affiliation as printed

   Charles University and General University Hospital, Department of Nephrology, Prague, Czech Republic

5. Hengguo Zhang

   Peking University First Hospital

   Affiliation as printed

   Peking University First Hospital, Renal Division, Beijing, China

6. Jonathan Barratt

   University of Leicester

   Affiliation as printed

   University of Leicester, Department of Cardiovascular Sciences, Leicester, United Kingdom