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NCT01572610 Clinical Trial

A Glomerular Filtration Rate (GFR) Measuring 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 GFR Measuring Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01572610
Other study ID # RTA 402-004
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 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 11
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

- Patients for whom Inulead® injection is contraindicated etc.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• RTA 402
once a day, oral administration

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: glomerular filtration rate measured by inulin clearance Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated. Up to 16 weeks
Primary Adverse Event collection and assessment Adverse Event collection Up to 16 weeks
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