Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients… (NCT01053936) | Clinical Trial Compass
CompletedPhase 2
Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease
United States129 participantsStarted 2010-01-31
Plain-language summary
This study assesses the effects of a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have a history of type 2 diabetes; diagnosis of type 2 diabetes should have been made at \>30 years of age (if diabetes developed at a younger age, C-peptide level may be obtained to confirm diagnosis);
✓. Patients must be at least 18 years of age;
✓. The average of 2 eGFR values collected during screening must be within 15 - 45 mL /min/1.73m2 inclusive.
✓. Patients must be receiving an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 8 weeks prior to screening, where the dose of the ACE inhibitor or the ARB is considered appropriate for that patient, and the patient has been stable and maintained on that dose for at least 8 weeks prior to randomization (Day 1). No change in ACE or ARB therapy should be anticipated or planned for the period of the study.
✓. Male and female patients must agree to use effective contraception during the entire study period and for at least 2 months after the last dose of study drug, unless documentation of infertility exists
✓. Women of child-bearing potential must have a negative serum pregnancy test result at screening and a confirmed negative urine pregnancy test result prior to administration of the first dose of study medication;
✓. Patient is willing and able to cooperate with all aspects of the protocol;
✓. Patient is willing and able to give written informed consent for study participation
Exclusion criteria
✕. Any patient with Type 1 (insulin-dependent; juvenile onset) diabetes; or any history of diabetic ketoacidosis;
What they're measuring
1
To assess a trend in mean change from baseline to Day 29 in eGFR (as estimated by the 4-component MDRD formula) with increasing doses of bardoxolone methyl (amorphous dispersion) in patients with Type 2 diabetes and CKD (eGFR 15-45 mL/min/1.73m2).
✕. Any patient with known non-diabetic renal disease, family history of a hereditary form of kidney disease, or patients with a history of a renal transplant.
✕. Any patient with clinical or renal biopsy evidence of any non-diabetic renal disease other than nephro-sclerosis;
✕. Any patient with blood pressure (BP) that is unable to be controlled to a systolic pressure (SeSBP) \<160 mmHg and a diastolic pressure (SeDBP) of \<90 mmHg. BP will be determined by the average of 3 readings, taken after being seated for at least 5-minutes. BP must be within this range taken at 2 separate time-points at least 4 days apart during the screening period;
✕. Any patient with Hemoglobin A1c level \>10% collected at screening;
✕. Any patient with cardiovascular disease as follows:
✕. Unstable angina pectoris within 3 months before study randomization;
✕. Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months before study randomization;