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NCT03608033 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
A Phase 3 study, sponsored by Omeros Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
NCT03608033: Clinical Trial Phase 3 study, sponsored by Omeros Corporation.
NCT03608033 is a Phase 3 study that was terminated before completion, run by Omeros Corporation. The registered enrollment target is 360 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03608033, a Phase 3 study, was terminated before completion, sponsored by Omeros Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
Study 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.
Primary Outcome
The Primary Endpoint of this Study is the Percent Change from Baseline in Log-transformed 24-hour UPE in g/Day at 36 Weeks in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/day.
Interventions
- BIOLOGICAL OMS721
- OTHER Vehicle (D5W or saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2024-01-12 |
| Phase | Phase 3 |
Why NCT03608033 stopped before completion
NCT03608033 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which OMS721 is the first listed.
NCT03608033 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03608033 about?
NCT03608033 is a clinical study titled "Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy". 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.
What is the current status of trial NCT03608033?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2018-04-05. Estimated completion is 2024-01-12.
What interventions are being tested in trial NCT03608033?
The interventions under investigation include: OMS721 (BIOLOGICAL), Vehicle (D5W or saline) (OTHER).
Who is sponsoring clinical trial NCT03608033?
This trial is sponsored by Omeros Corporation, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03608033's enrollment target sits among peer trials
360 1008th of 2000 higher than 980 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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