A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL

Description

This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.

Study Start Date

March, 02 2017

Estimated Completion Date

December 2020

Interventions

  • Drug: Placebo Oral Capsule
  • Drug: Bardoxolone Methyl

Study ID

Reata Pharmaceuticals, Inc. -- RTA 402-C-1603

Status

Recruiting

Trial ID

NCT03019185

Study Type

Interventional

Trial Phase

Phase 2/Phase 3

Enrollment Quota

210

Sponsor

Reata Pharmaceuticals, Inc.

Inclusion Criteria

  • Male and female patients 12 ? age ? 60 upon study consent
  • Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or COL4A5) or histologic assessment using electron microscopy
  • Screening eGFR ? 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) ? 3500 mg/g at Screen B visit
  • If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB), the medications must remain the same for at least 6 weeks prior to the Screen A visit and during Screening. The dosage of ACE inhibitor and/or ARB must also be stable for 2 weeks prior to the Screen A visit and remain the same through Day 1 (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to the Screen A visit
  • Adequate bone marrow reserve and organ function at the Screen A visit
  • Able to swallow capsules
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

  • Prior exposure to bardoxolone methyl
  • Ongoing chronic hemodialysis or peritoneal dialysis therapy
  • Renal transplant recipient
  • B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit
  • Uncontrolled diabetes (HbA1c > 11.0%) 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
  • History of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
  • Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Screen A visit after a period of rest
  • Systolic BP < 90 mm Hg at Screen A visit after a period of rest
  • History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas
  • Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study
  • 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
  • Known hypersensitivity to any component of the study drug

Gender

All

Ages

12 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (66)

Study Location Distance Name Phone Email
Nephrology Associates PC - Flushing, New York 44.0 miles None None None
Nephrology Associates PC - Flushing, New York 44.0 miles None None None
Nephrology Associates PC - Flushing, New York 44.0 miles None None None
Nephrology Associates PC - Flushing, New York 44.0 miles None None None
Columbia University Nephrology - New York, New York 44.8 miles None None None
Rhode Island Hospital - Providence, Rhode Island 104.1 miles None None None
Tufts Medical Center - Boston, Massachusetts 137.7 miles None None None
Biolab Research LLC - Rockville, Maryland 253.9 miles None None None
Biolab Research LLC - Rockville, Maryland 253.9 miles None None None
Biolab Research LLC - Rockville, Maryland 253.9 miles None None None
Biolab Research LLC - Rockville, Maryland 253.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 435.4 miles None None None
Nephrology Associates PLLC - Winston-Salem, North Carolina 523.2 miles None None None
Nephrology Associates PLLC - Winston-Salem, North Carolina 523.2 miles None None None
Nephrology Associates PLLC - Winston-Salem, North Carolina 523.2 miles None None None
Nephrology Associates PLLC - Winston-Salem, North Carolina 523.2 miles None None None
University of Michigan - Ann Arbor, Michigan 545.4 miles None None None
University of Cincinnati - Cincinnati, Ohio 612.8 miles None None None
South Carolina Nephrology Hypertension Center Inc - Orangeburg, South Carolina 677.3 miles None None None
South Carolina Nephrology Hypertension Center Inc - Orangeburg, South Carolina 677.3 miles None None None
South Carolina Nephrology Hypertension Center Inc - Orangeburg, South Carolina 677.3 miles None None None
South Carolina Nephrology Hypertension Center Inc - Orangeburg, South Carolina 677.3 miles None None None
NorthShore University Health System - Evanston, Illinois 749.4 miles None None None
Emory University School of Medicine and Childrens Healthcare of Atlanta - Atlanta, Georgia 795.6 miles None None None
Emory University School of Medicine and Childrens Healthcare of Atlanta - Atlanta, Georgia 795.6 miles None None None
Emory University School of Medicine and Childrens Healthcare of Atlanta - Atlanta, Georgia 795.6 miles None None None
Emory University School of Medicine and Childrens Healthcare of Atlanta - Atlanta, Georgia 795.6 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 916.1 miles None None None
Washington University School of Medicine - Saint Louis, Missouri 919.8 miles None None None
University of Minnesota Division of Pediatric Nephrology - Minneapolis, Minnesota 1,041.2 miles None None None
University of Minnesota Division of Pediatric Nephrology - Minneapolis, Minnesota 1,041.2 miles None None None
University of Minnesota Division of Pediatric Nephrology - Minneapolis, Minnesota 1,041.2 miles None None None
University of Minnesota Division of Pediatric Nephrology - Minneapolis, Minnesota 1,041.2 miles None None None
South Florida Research Institute - Lauderdale Lakes, Florida 1,117.7 miles None None None
Childrens Mercy Hospital Kansas City - Kansas City, Missouri 1,136.3 miles None None None
Childrens Mercy Hospital Kansas City - Kansas City, Missouri 1,136.3 miles None None None
Childrens Mercy Hospital Kansas City - Kansas City, Missouri 1,136.3 miles None None None
Childrens Mercy Hospital Kansas City - Kansas City, Missouri 1,136.3 miles None None None
Renal Disease Research Institute - Dallas, Texas 1,422.5 miles None None None
Southwest Houston Research - Houston, Texas 1,486.1 miles None None None
Clinical Advancement Center - San Antonio, Texas 1,634.2 miles None None None
Denver Nephrologists PC - Denver, Colorado 1,662.2 miles None None None
University of Utah Health - Salt Lake City, Utah 2,001.2 miles None None None
AKDHC Medical Research Services LLC - Phoenix, Arizona 2,184.6 miles None None None
AKDHC Medical Research Services LLC - Phoenix, Arizona 2,184.6 miles None None None
AKDHC Medical Research Services LLC - Phoenix, Arizona 2,184.6 miles None None None
AKDHC Medical Research Services LLC - Phoenix, Arizona 2,184.6 miles None None None
Boise Kidney Hypertension Institute - Meridian, Idaho 2,188.1 miles None None None
Boise Kidney Hypertension Institute - Meridian, Idaho 2,188.1 miles None None None
Boise Kidney Hypertension Institute - Meridian, Idaho 2,188.1 miles None None None
Boise Kidney Hypertension Institute - Meridian, Idaho 2,188.1 miles None None None
Boise Kidney Hypertension Institute - Caldwell, Idaho 2,203.1 miles None None None
Boise Kidney Hypertension Institute - Caldwell, Idaho 2,203.1 miles None None None
Boise Kidney Hypertension Institute - Caldwell, Idaho 2,203.1 miles None None None
Boise Kidney Hypertension Institute - Caldwell, Idaho 2,203.1 miles None None None
Scripps Clinic Nephrology - La Jolla, California 2,474.1 miles None None None
Scripps Clinic Nephrology - La Jolla, California 2,474.1 miles None None None
Scripps Clinic Nephrology - La Jolla, California 2,474.1 miles None None None
Scripps Clinic Nephrology - La Jolla, California 2,474.1 miles None None None
Valley Childrens Healthcare - Madera, California 2,475.5 miles None None None
Valley Childrens Healthcare - Madera, California 2,475.5 miles None None None
Valley Childrens Healthcare - Madera, California 2,475.5 miles None None None
Valley Childrens Healthcare - Madera, California 2,475.5 miles None None None
Academic Medical Research Institute - Los Angeles, California 2,485.3 miles None None None
David Geffen School of Medicine at UCLA - Los Angeles, California 2,499.3 miles None None None
UCSF - San Francisco, California 2,603.0 miles None None None

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