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NCT01574365 Clinical Trial

A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:
A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01574365
Other study ID # RTA 402-003
Secondary ID
Status Terminated
Phase Phase 2
First received April 4, 2012
Last updated February 28, 2017
Start date February 2012
Est. completion date November 2013

Study information
Verified date February 2017
Source Kyowa Hakko Kirin Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 53
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• RTA 402

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy:Changes in eGFR Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation. Up to 16 weeks
Primary Adverse event collection and assessment Adverse Event collection and assessment will be done for all treated subjects. Up to 16 weeks
Secondary Profile of Pharmacokinetics Relationship between the study drug dose and the trough concentration of study drug Baseline, week 4, 8 and 12.
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