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About
This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.
Full description
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
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Inclusion criteria
Exclusion criteria
History of Autosomal Dominant Polycystic Kidney Disease
Currently Active Systemic Lupus Erythematosus
History of Hepatitis B Surface Antigen +
History of Hepatitis C Antibody + being treated with antiviral therapy
History of an organ transplant
A planned renal transplant from a living donor during the study
History of hospitalization for congestive heart failure or pulmonary edema within 12 weeks before study randomization
History of cirrhosis of the liver
History of amyloidosis or light chain nephropathy
History of hemoglobin A1c level > 11.0% (97 mmol/mol) within 12 weeks before study randomization
History of recently active cardiovascular disease defined as:
History of a diagnostic or interventional procedure that required intravenous administration of an iodinated contrast agent or gadolinium within 12 weeks before study randomization
History of known severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy
History of known 2o or 3o atrioventricular block not successfully treated with a pacemaker
History or resuscitated sudden cardiac death
History of an automatic implantable defibrillator
QTc greater than 0.50 seconds on an ECG obtained during either Screen A or Screen B visits
A serum magnesium level less than 1.4 meq/L on either Screen A or Screen B visit laboratory test results
History of systemic immunosuppression for more than 15 days, cumulatively, within the 12 weeks prior to study randomization or anticipated need for more than 15 days of immunosuppression during the study
Total bilirubin, aspartate transaminase (AST), or alanine transaminase (ALT) level greater than the upper limit of normal (ULN) or alkaline phosphatase level greater than two times the ULN on either the Screen A and Screen B visit laboratory test results
Known hypersensitivity to any component of the study drug
Current history of drug or alcohol abuse, as assessed by the investigator
History of clinically significant infection requiring intravenous administration of antibiotics or hospitalization within 12 weeks before study randomization
In patients who have been on peritoneal dialysis for ≥ 6 months, two or more episodes of peritonitis in the 6 months before study randomization. In patients who have been on peritoneal dialysis for <6 months, one episode of peritonitis before study randomization
History of a diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix
History of a clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the patient while involved in the study
Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
Participation in a clinical study involving any intervention within 30 days prior to Screen A visit, concurrent participation in such a study, or participation in a prior clinical study involving bardoxolone methyl in any form
Female patients who are pregnant, intend to become pregnant during this study, or are nursing
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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