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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 : Recruiting
First Posted : December 8, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

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.


Condition or disease Intervention/treatment Phase
IgA Nephropathy CKD Associated With Type 1 Diabetes Focal Segmental Glomerulosclerosis Autosomal Dominant Polycystic Kidney Drug: Bardoxolone methyl capsules Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases
Actual Study Start Date : December 26, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
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.
Drug: Bardoxolone methyl capsules
Bardoxolone 5 mg capsules
Other Name: RTA 402

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.
Drug: Bardoxolone methyl capsules
Bardoxolone 5 mg capsules
Other Name: RTA 402




Primary Outcome Measures :
  1. Increase in eGFR from baseline [ Time Frame: 12 weeks ]
    To assess the increase in eGFR from baseline to week 12


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366337


Contacts
Contact: Angela Germany 469-442-4900 phoenix@reatapharma.com

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Sponsors and Collaborators
Reata Pharmaceuticals, Inc.

Additional Information:
Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03366337     History of Changes
Other Study ID Numbers: 402-C-1702
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reata Pharmaceuticals, Inc.:
IgA Nephropathy
CKD associated with type 1 diabetes
Focal segmental glomerulosclerosis
Autosomal dominant polycystic kidney disease
IgAN
FSGS
ADPKD
Bardoxolone methyl
CDDO-ME
RTA 402

Additional relevant MeSH terms:
Kidney Diseases
Diabetes Mellitus, Type 1
Renal Insufficiency, Chronic
Polycystic Kidney Diseases
Glomerulonephritis, IGA
Polycystic Kidney, Autosomal Dominant
Glomerulosclerosis, Focal Segmental
Urologic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Renal Insufficiency
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Glomerulonephritis
Nephritis