Chronic Kidney Disease, Type 2 Diabetes
Conditions
Keywords
Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Complications, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Renal Insufficiency, Urologic Diseases, bardoxolone methyl
Brief summary
The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when this compound is administered once daily for 16 weeks in an intrapatient dose escalation design.
Interventions
DRUGRTA 402
DRUGPlacebo
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* CKD patients with type 2 diabetes mellitus * Patients whose estimated GFR levels are eligible for this study * Patients being treated with stable dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blocker (ARB) etc.
Exclusion criteria
* Patients with type 1 diabetes mellitus * Patients with known non-diabetic renal disease * Patients with a history of renal transplantation * Patients with mean systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 90 mmHg * Patients with Hemoglobin A1c \> 10% * Patients with cardiovascular disease specified in the study protocol etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number and types of adverse events | Up to 16 weeks | Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm |
| Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR | Up to 16 weeks | Change in GFR from baseline to 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR | Up to 16 weeks | Change in eGFR from baseline to 16 weeks |
| Profiles of pharmacokinetics of plasma RTA 402 concentration: Trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state | Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment | Relationship between the study drug dose and the trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state |
Countries
Japan
Outcome results
None listed