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NCT03393013 · ClinicalTrials.gov registry record · Phase 1
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
A Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by Kezar Life Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT03393013: Completed Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by Kezar Life Sciences.
NCT03393013 is a Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis that has completed, run by Kezar Life Sciences. The registered enrollment target is 69 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03393013, a Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, has completed, sponsored by Kezar Life Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
Primary Outcome
The safety and tolerability of zetomipzomib (KZR-616) when administered as a subcutaneous injection weekly for 13 weeks in adult patients with systemic lupus erythematous (SLE) with and without nephritis, as assessed by number of patients who experienced at least one treatment-related treatment-emergent adverse event. For additional information about the safety and tolerability of KZR-616, please reference the adverse events section of this posting.
Conditions Studied
Interventions
- DRUG KZR-616
Study Locations (20)
Florida
- SouthCoast Research Center, Inc. - Miami
- Hope Clinical Trials, Inc. - Miami
- Omega Research Maitland - Orlando
- Arthritis Center, Inc - Palm Harbor
- Advent Health Medical Group - Tampa
New York
- Northwell Health - Great Neck
- NYU Langone Orthopedic Center - Seligman Center for Advanced Therapeutics - New York
- University of Rochester Medical Center - Rochester
Texas
- MedResearch, Inc. - El Paso
- Accurate Clinical Research, Inc. - Houston
- Accurate Clinical Management, LLC - Houston
California
- Academic Medical Research Institute - Los Angeles
- Inland Rheumatology Clinical Trials, Inc. - Upland
Victoria
- Monash Health - Clayton
- The Royal Melbourne Hospital - Parkville
Iowa
- University of Iowa - Iowa City
Ohio
- The Ohio State University Wexner Medical Center - Columbus
South Carolina
- SC Nephrology & Hypertension Center, Inc. - Orangeburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2022-08-04 |
| Phase | Phase 1 |
What the finished NCT03393013 record still lists
NCT03393013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which KZR-616 is the first listed.
NCT03393013 names 20 study sites across 10 states, led by Florida, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT03393013 about?
NCT03393013 is a clinical study titled "A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis". This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
What is the current status of trial NCT03393013?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2018-02-20. Estimated completion is 2022-08-04.
What conditions does trial NCT03393013 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Lupus Nephritis.
What interventions are being tested in trial NCT03393013?
The interventions under investigation include: KZR-616 (DRUG).
Who is sponsoring clinical trial NCT03393013?
This trial is sponsored by Kezar Life Sciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03393013 being conducted?
This trial has 20 study locations across California, Florida, Iowa, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03393013's enrollment target sits among peer trials
69 68th of 99 higher than 32 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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.
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