A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
Public ClinicalTrials.gov record NCT03366337. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03366337
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 26, 2017 (Actual)
- Primary completion
- Jan 2, 2019 (Actual)
- Completion
- Jan 29, 2019 (Actual)
- Last update posted
- Jun 3, 2025
2017 – 2019
United States locations
- U.S. sites
- 30
- U.S. states
- 23
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | — |
| Phoenician Centers for Research & Innovation (PCRI) | Phoenix | Arizona | 85021 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| Denver Nephrology | Denver | Colorado | 80230 | — |
| Gulfcoast Endocrine and Diabetes Center | Clearwater | Florida | 33756 | — |
| South Florida Research Institute | Lauderdale Lakes | Florida | 33313 | — |
| Coastal Nephrology Associates | Port Charlotte | Florida | 33952 | — |
| Kidney Care Augusta | Augusta | Georgia | 30909 | — |
| Boise Kidney & Hypertension, PLLC | Caldwell | Idaho | 83605 | — |
| Boise Kidney & Hypertension, PLLC | Meridian | Idaho | 83642 | — |
| Research By Design | Evergreen Park | Illinois | 60805 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Four Rivers Clinical Research, Inc | Paducah | Kentucky | 42003 | — |
| Northwest Louisiana Nephrology | Shreveport | Louisiana | 71101 | — |
| Tufts Medical Center - Division of Nephrology Tufts Medical Center | Boston | Massachusetts | 02110 | — |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Columbia University Medical Center - Nephrology | New York | New York | 10032 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Physician's East Endocrine Research | Greenville | North Carolina | 27834 | — |
| Remington-Davis Clinical Research | Columbus | Ohio | 43215 | — |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18017 | — |
| The Warren Alpert School of Brown University | Providence | Rhode Island | 02903 | — |
| Nephrology Associates | Chattanooga | Tennessee | 37404 | — |
| Research Management, Inc. | Austin | Texas | 78751 | — |
| Renal Disease Research Intitute | Dallas | Texas | 75235 | — |
| Renal Associates, PA | San Antonio | Texas | 78215 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| Mendez Center for Clinical Research LLC | Fairfax Station | Virginia | 22039 | — |
| Larry Stonesifer, M.D. | Federal Way | Washington | 98003 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03366337, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03366337 live on ClinicalTrials.gov.