Diabetic Kidney Disease
Conditions
Keywords
Bardoxolone Methyl, Diabetic Kidney Disease, Diabetes Mellitus, Kidney Diseases
Brief summary
The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will also be evaluated.
Interventions
Bardoxolone methyl 5 mg capsules
DRUGPlacebo
Capsules containing an inert placebo
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized double-blinded part followed by open label extension part.
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients with DKD * Mean eGFR ≥ 15 and \< 60 mL/min/1.73 m² * Albumin/creatinine ratio (ACR) ≤ 3500 mg/g Cr * Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) with no change in dosage or medication etc.
Exclusion criteria
* Diabetes mellitus that is neither type 1 nor type 2 * Decreased renal function mainly attributed to a non-diabetic cause * History of renal transplantation or upcoming preemptive renal transplantation * Confirmed mean systolic blood pressure \> 160 mmHg or a confirmed mean diastolic blood pressure \> 90 mmHg during the 8-week period before screening * Hemoglobin A1c level \> 10.0% during screening * Serum albumin level ≤ 3.0 g/dL during screening * Cardiovascular disease specified in the study protocol * History of cardiac failure * BNP level \> 200 pg/mL during screening etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD | Through double-blind part completion, approximately 3 to 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of a ≥ 40% decrease in eGFR from baseline or ESRD | Through double-blind part completion, approximately 3 to 4 years |
| Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD | Through double-blind part completion, approximately 3 to 4 years |
| Time to onset of ESRD | Through double-blind part completion, approximately 3 to 4 years |
| Change in eGFR from baseline at each evaluation time point | Through double-blind part completion, approximately 3 to 4 years |
Countries
Japan
Outcome results
None listed