Chronic Kidney Disease, Type 2 Diabetes
Conditions
Keywords
CKD patients with type 2 diabetes
Brief summary
A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
Detailed description
An exploratory study to investigate the effects of RTA 402 on glomerular filtration rate in CKD patients with type 2 diabetes mellitus. To evaluate the safety of RTA 402.
Interventions
DRUGRTA 402
once a day, oral administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 * Patients for whom Inulead® injection is contraindicated etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: glomerular filtration rate measured by inulin clearance | Up to 16 weeks | Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated. |
| Adverse Event collection and assessment | Up to 16 weeks | Adverse Event collection |
Countries
Japan
Outcome results
None listed