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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03366337
Date of registration: 04/12/2017
Prospective Registration: Yes
Primary sponsor: Reata Pharmaceuticals, Inc.
Public title: A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX PHOENIX
Scientific title: A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases
Date of first enrolment: December 26, 2017
Target sample size: 103
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03366337
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female patients 18 = age = 65 upon study consent;

- Screening eGFR (average of Screen A and Screen B eGFR values) = 30 and = 90
mL/min/1.73 m2. The two eGFR values collected at Screen A and Screen B visits used to
determine eligibility must have a percent difference = 25%;

- Albumin to creatinine ratio (ACR) = 2500 mg/g at Screen B visit;

- If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II
receptor blocker (ARB), patients should be prescribed the maximally tolerated labeled
daily dose (MTLDD) for at least 6 weeks prior to the Screen A visit;

- For patients enrolling in T1D Cohort: Diagnosis of type 1 diabetes confirmed by
fasting C-peptide level. Diagnosis must have been made = 35 years of age; and
prescribed stable dose of insulin to maintain adequate glucose control for at least 6
months prior to the Screen A visit;

- For patients enrolling in IgAN Cohort: Biopsy-confirmed IgA nephropathy;

- For patients enrolling in FSGS Cohort: Biopsy-confirmed FSGS that is not due to known
secondary causes including morbid obesity, decreased renal mass, viral infections,
drug-induced nephrotoxicity, or prior history of vasculitis;

- For patients enrolling in ADPKD Cohort: Genetic confirmation of PKD1 mutation;

- Adequate bone marrow reserve and organ function at the Screen A visit as follows:
Hematologic: Absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L,
hemoglobin (Hgb) = 9 g/dL; and Hepatic: Total bilirubin (TBL) = 1.5 times the upper
limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase
(AST) = 1.5 times ULN.

Exclusion Criteria:

- Kidney or any other solid organ transplant recipient or a planned transplant during
the study;

- B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;

- Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or
during Screening;

- Serum albumin < 3 g/dL at Screen A visit;

- Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks
prior to randomization or anticipated need for immunosuppression during the study;

- For patients enrolling in IgAN Cohort: Systemic manifestations of Henoch-Schonlein
purpura within 1 year prior to Screen A visit; or have used belimumab, eculizumab, or
rituximab within 6 months prior to Screen A visit;

- For patients enrolling in ADPKD Cohort: Receiving tolvaptan;

- Cerebrovascular event (stroke, transient ischemic attack) or aneurysm within 6 months
prior to Screen A visit or during Screening;

- History of clinically significant left-sided heart disease and/or clinically
significant cardiac disease;

- Uncontrolled systemic hypertension;

- Systolic BP < 90 mm Hg at Screen A visit after a period of rest;

- History of malignancy within 2 years prior to Screen A visit, with the exception of
localized skin or cervical carcinomas;

- Uncontrolled diabetes (HbA1c > 10.0%) at Screen A visit;

- Untreated or uncontrolled active bacterial, fungal, or viral infection;

- Participation in other interventional clinical studies within 30 days prior to Day 1;

- Unwilling to practice acceptable methods of birth control (both males who have
partners of child-bearing potential and females of childbearing potential) during
Screening, while taking study drug, and for at least 30 days after the last dose of
study drug is ingested;

- Women who are pregnant or breastfeeding.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Autosomal Dominant Polycystic Kidney
CKD Associated With Type 1 Diabetes
Focal Segmental Glomerulosclerosis
IgA Nephropathy
Intervention(s)
Drug: Bardoxolone methyl capsules
Primary Outcome(s)
Increase in eGFR from baseline [Time Frame: 12 weeks]
Secondary Outcome(s)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 12 weeks]
Secondary ID(s)
402-C-1702
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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