Chronic Kidney Disease, Type 2 Diabetes
Conditions
Keywords
CKD patients with type 2 diabetes
Brief summary
A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
Detailed description
To evaluate the efficacy and safety of RTA 402 in patients with type 2 diabetes mellitus. To evaluate the safety and tolerability of RTA 402.
Interventions
DRUGRTA 402
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* CKD patients with type 2 diabetes mellitus * Patients whose eGFR levels are eligible for this study * Patients being treated with stable dose of ACE inhibitors and/or ARB etc.
Exclusion criteria
* Patients with Type 1 diabetes * Patients with known non-diabetic renal disease * Patients with a history of renal transplantation * Patients with mean SBP \> 160 mmHg or mean DBP \> 90 mmHg * Patients with HbA1C \> 10% * Patients with cardiovascular disease specified in the study protocol etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy:Changes in eGFR | Up to 16 weeks | Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation. |
| Adverse event collection and assessment | Up to 16 weeks | Adverse Event collection and assessment will be done for all treated subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Pharmacokinetics | Baseline, week 4, 8 and 12. | Relationship between the study drug dose and the trough concentration of study drug |
Countries
Japan
Outcome results
None listed