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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 is a Phase 3 study that was terminated before completion, run by Omeros Corporation. The registered enrollment target is 360 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03608033
The ClinicalTrials.gov registry entry for NCT03608033 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Omeros Corporation, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which OMS721 is the first listed.
NCT03608033 reports 0 study locations.
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.
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