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A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX (PHOENIX)

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ClinicalTrials.gov Identifier: NCT03366337
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2017
First Posted Date  ICMJE December 8, 2017
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE December 26, 2017
Actual Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
Increase in eGFR from baseline [ Time Frame: 12 weeks ]
To assess the increase in eGFR from baseline to week 12
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 weeks ]
Safety will be assessed by monitoring laboratory results, vital sign measurements, electrocardiogram results, adverse events, and serious adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
Official Title  ICMJE A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • IgA Nephropathy
  • CKD Associated With Type 1 Diabetes
  • Focal Segmental Glomerulosclerosis
  • Autosomal Dominant Polycystic Kidney
Intervention  ICMJE Drug: Bardoxolone methyl capsules
Bardoxolone 5 mg capsules
Other Name: RTA 402
Study Arms  ICMJE
  • Experimental: Patients with baseline ACR > 300 mg/g but ≤ 2,500 mg/g
    Patients will receive bardoxolone methyl throughout the study. Patients with baseline ACR > 300 mg/g will be titrated to a maximum dose of 30 mg of bardoxolone methyl. They will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2, 20 mg at week 4, and then to 30 mg at Week 6.
    Intervention: Drug: Bardoxolone methyl capsules
  • Experimental: Patients with baseline ACR ≤ 300 mg/g
    Patients will receive bardoxolone methyl throughout the study. Patients with baseline ACR ≤ 300 mg/g will be titrated to a maximum dose of 20 mg of bardoxolone methyl. They will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2 and 20 mg at week 4.
    Intervention: Drug: Bardoxolone methyl capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2019)
103
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2017)
100
Actual Study Completion Date  ICMJE January 29, 2019
Actual Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03366337
Other Study ID Numbers  ICMJE 402-C-1702
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Reata Pharmaceuticals, Inc.
Study Sponsor  ICMJE Reata Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reata Pharmaceuticals, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP