Last updated on August 2018

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

Brief description of study

The purpose of this study is to evaluate the safety and efficacy of OMS721 in patients with IgA nephropathy. The study will assess proteinuria by 24-hour urine protein excretion (UPE) in g/day at 24 weeks from beginning of treatment.

Detailed Study Description

This is a Phase 3, double-blind, randomized, placebo-controlled, study in patients aged 18 years and above with a biopsy-confirmed diagnosis of IgAN and with 24-hour UPE that is > 1 g/day at baseline. During the study, all patients will continue optimized renin-angiotensin system (RAS) blockade. The study consists of five periods: Screening, Run-In, Initial Treatment (Weeks 1-12), Response Evaluation (Weeks 13-24), and Follow-Up (Weeks 25-144). Patients are assessed for re-treatment based on their response to 24-hour UPE. Additional treatment will be given to patients who relapse or who have partial response following the Initial Treatment Period.

Approximately 430 patients are to enrolled in two groups of 215 patients per arm.

Clinical Study Identifier: NCT03608033

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Omeros Investigational Site

Flushing, NY United States
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Recruitment Status: Open

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