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NCT03366337 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
A Phase 2 study of Focal Segmental Glomerulosclerosis and IgA Nephropathy, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT03366337: Completed Phase 2 study of Focal Segmental Glomerulosclerosis and IgA Nephropathy, sponsored by Biogen.
NCT03366337 is a Phase 2 study of Focal Segmental Glomerulosclerosis and IgA Nephropathy that has completed, run by Biogen. The registered enrollment target is 103 participants, below the 231-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03366337, a Phase 2 study of Focal Segmental Glomerulosclerosis and IgA Nephropathy, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients will be enrolled in disease specific cohorts within the trial, and effectiveness of bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD. All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks after the end of treatment.
Primary Outcome
To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
Conditions Studied
Interventions
- DRUG Bardoxolone methyl capsules
Study Locations (20)
Florida
- Gulfcoast Endocrine and Diabetes Center - Clearwater
- South Florida Research Institute - Lauderdale Lakes
- Coastal Nephrology Associates - Port Charlotte
Idaho
- Boise Kidney & Hypertension, PLLC - Caldwell
- Boise Kidney & Hypertension, PLLC - Meridian
Missouri
- Clinical Research Consultants, LLC - Kansas City
- Washington University School of Medicine - St Louis
New York
- Columbia University Medical Center - Nephrology - New York
- Jacobi Medical Center - The Bronx
Alabama
- University of Alabama Birmingham - Birmingham
Arizona
- Phoenician Centers for Research & Innovation (PCRI) - Phoenix
California
- University of California Los Angeles - Los Angeles
Colorado
- Denver Nephrology - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2017-12-26 |
| Est. Completion | 2019-01-29 |
| Phase | Phase 2 |
What the finished NCT03366337 record still lists
NCT03366337 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 231-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (55% lower).
The record links to 4 conditions, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 1 intervention - of which Bardoxolone methyl capsules is the first listed.
NCT03366337 names 20 study sites across 15 states, led by Florida, Idaho, Missouri.
Frequently Asked Questions
What is clinical trial NCT03366337 about?
NCT03366337 is a clinical study titled "A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX". This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS...
What is the current status of trial NCT03366337?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2017-12-26. Estimated completion is 2019-01-29.
What conditions does trial NCT03366337 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis, IgA Nephropathy, Autosomal Dominant Polycystic Kidney, CKD Associated With Type 1 Diabetes.
What interventions are being tested in trial NCT03366337?
The interventions under investigation include: Bardoxolone methyl capsules (DRUG).
Who is sponsoring clinical trial NCT03366337?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03366337 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03366337's enrollment target sits among peer trials
103 7th of 19 higher than 12 of 19 other Focal Segmental Glomerulosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Focal Segmental Glomerulosclerosis 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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