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



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Nephrology, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 65
Updated:3/16/2019
Start Date:December 26, 2017
End Date:August 2019

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

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.


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.
We found this trial at
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Evergreen Park, Illinois 60805
Principal Investigator: Paul Crawford, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Dana Rizk, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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2300 East Third Street
Chattanooga, Tennessee 37404
423-778-3861
Principal Investigator: Claude Galphin, MD
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Chattanooga, TN
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1335 Dublin Road
Columbus, Ohio 43215
614-487-2560
Principal Investigator: Kevin Schroeder, MD
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Columbus, OH
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Anjay Rastogi, MD
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Augusta, Georgia 30909
Principal Investigator: Syed N Babar, MD
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Austin, Texas 78751
Principal Investigator: Judith Betts, MD
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Bethlehem, Pennsylvania 18017
Principal Investigator: Nelson Kopyt, MD
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35 Kneeland Street
Boston, Massachusetts 02110
Principal Investigator: Lesley Inker, MD
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Boston, MA
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Principal Investigator: Anjali Acharya, MD
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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4620 Enterprise Way
Caldwell, Idaho 83605
Principal Investigator: Arnold L Silva, MD
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Clearwater, Florida 33756
Principal Investigator: Paul Denker, MD
Phone: 727-441-4581
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1420 Viceroy Drive
Dallas, Texas 75235
Principal Investigator: Tapan Patel, MD
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Denver, Colorado 80230
Principal Investigator: Geoffrey Block, MD
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Denver, CO
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Fairfax Station, Virginia 22039
Principal Investigator: Ramon Mendez, MD
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Federal Way, Washington 98003
Principal Investigator: Larry Stonesifer, MD
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Federal Way, WA
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1006 WH Smith Boulevard
Greenville, North Carolina 27834
Principal Investigator: Mark Warren, MD
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Cassandra Kimber, MD
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, Missouri 64111
Principal Investigator: Ahmed Awad, MD
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Lauderdale Lakes, Florida 33311
Principal Investigator: Edouard R Martin, MD
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3525 East Louise Drive
Meridian, Idaho 83642
Principal Investigator: Arnold Silva, MD
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Meridian, ID
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New York, New York 10032
Principal Investigator: Gerald Appel, MD
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Paducah, Kentucky 42003
Principal Investigator: Cynthia Bowman-Stroud, MD
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Phoenix, Arizona 85021
Principal Investigator: Kenneth Boren, MD
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3221 South Tamiami Trail
Port Charlotte, Florida 33952
Principal Investigator: Rohit Pankhaniya, MD
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Providence, Rhode Island 02903
Principal Investigator: Reginald Gohh, MD
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: George Jarad, MD
Phone: 314-362-9096
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas
Principal Investigator: Pablo Pergola, MD
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Shreveport, Louisiana 71101
Principal Investigator: Marwan Kaskas, MD
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West Jordan, Utah 84088
Principal Investigator: Barbara Rizzardi, MD
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