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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03366337
Other study ID # 402-C-1702
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 26, 2017
Est. completion date January 29, 2019

Study information

Verified date February 2024
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date January 29, 2019
Est. primary completion date January 2, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bardoxolone methyl capsules
Bardoxolone 5 mg capsules

Locations

Country Name City State
United States Kidney Care Augusta Augusta Georgia
United States Research Management, Inc. Austin Texas
United States Northeast Clinical Research Center, LLC Bethlehem Pennsylvania
United States University of Alabama Birmingham Birmingham Alabama
United States Tufts Medical Center - Division of Nephrology Tufts Medical Center Boston Massachusetts
United States Jacobi Medical Center Bronx New York
United States Boise Kidney & Hypertension, PLLC Caldwell Idaho
United States Nephrology Associates Chattanooga Tennessee
United States Gulfcoast Endocrine and Diabetes Center Clearwater Florida
United States Remington-Davis Clinical Research Columbus Ohio
United States Renal Disease Research Intitute Dallas Texas
United States Denver Nephrology Denver Colorado
United States Research By Design Evergreen Park Illinois
United States Mendez Center for Clinical Research LLC Fairfax Station Virginia
United States Larry Stonesifer, M.D. Federal Way Washington
United States Physician's East Endocrine Research Greenville North Carolina
United States Clinical Research Consultants, LLC Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States South Florida Research Institute Lauderdale Lakes Florida
United States University of California Los Angeles Los Angeles California
United States Boise Kidney & Hypertension, PLLC Meridian Idaho
United States Columbia University Medical Center - Nephrology New York New York
United States Four Rivers Clinical Research, Inc Paducah Kentucky
United States Phoenician Centers for Research & Innovation (PCRI) Phoenix Arizona
United States Coastal Nephrology Associates Port Charlotte Florida
United States The Warren Alpert School of Brown University Providence Rhode Island
United States Washington University School of Medicine Saint Louis Missouri
United States Renal Associates, PA San Antonio Texas
United States Northwest Louisiana Nephrology Shreveport Louisiana
United States Advanced Clinical Research West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
Reata, a wholly owned subsidiary of Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 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. 12 weeks after participant receives the first dose
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