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

NCT03608033 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-12-09

Study results available
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Summary

The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2 g/day) assessed at 36 weeks from baseline.

Conditions

Interventions

BIOLOGICAL

OMS721

Biological: OMS721

OTHER

Vehicle (D5W or saline)

5% Dextrose in water or normal saline solution

Sponsors & Collaborators

  • Omeros Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2024-01-12
Completion
2024-01-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Greece
  • Hungary
  • India
  • Italy
  • Lithuania
  • Poland
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03608033 on ClinicalTrials.gov