A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS-IgAN)

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Study Overview

This study will use a new investigational study drug called OMS721 in people with Immunoglobulin A (IgA) Nephropathy. This kidney disease produces abnormal amounts of a protein called IgA in the kidney that damage the filtering units or glomeruli. Glomeruli are tiny filtering units in the kidney that remove excess fluid and waste (and other toxins) from your blood stream.

Study Description

The purpose of this study is to test the safety and describe the effect of OMS721, an "investigational drug", in people with IgA Nephropathy. "Investigational drug" means that the drug has not been approved for sale in the United States by the U.S. Food and Drug Administration (U.S. FDA) for this purpose.

You are being asked to consider taking part in this study because you have IgA Nephropathy. Researchers want to find out if giving OMS721 investigational drug to people with IgA Nephropathy is safe and tolerable and may help treat your condition.

This is the second time that OMS721 is being studied in people with IgA Nephropathy. In an ongoing study of OMS721 for patients with glomerular nephropathies (kidney diseases), a total of 29 patients have taken part as of 19 February 2019. Nineteen of those patients had IgA Nephropathy. OMS721 is being studied in people with other diseases. As of 19 February 2019, 54 patients have received OMS721 in a study with another disease known as Thrombotic Microangiopathies (TMA). In addition, in two other studies, at least 131 healthy volunteers have received OMS721.

  • Study Identifier: 832096

Recruitment Status

Open

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