Back to resultsA Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
Primary Purpose
Chronic Kidney Disease, Type 2 Diabetes
Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
RTA 402
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD patients with type 2 diabetes
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RTA 402
Arm Description
Outcomes
Primary Outcome Measures
Efficacy: glomerular filtration rate measured by inulin clearance
Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated.
Adverse Event collection and assessment
Adverse Event collection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01572610
Brief Title
A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
Official Title
A Phase 2 GFR Measuring Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Study Start Date
February 2012 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Type 2 Diabetes
Keywords
CKD patients with type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RTA 402
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RTA 402
Intervention Description
once a day, oral administration
Primary Outcome Measure Information:
Title
Efficacy: glomerular filtration rate measured by inulin clearance
Description
Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated.
Time Frame
Up to 16 weeks
Title
Adverse Event collection and assessment
Description
Adverse Event collection
Time Frame
Up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Koga city
State/Province
Ibaraki
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
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