Back to resultsA 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 etc.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
RTA402
RTA402 Low
RTA402 Medium-low
RTA402 Medium-high
Arm Description
Outcomes
Primary Outcome Measures
Efficacy:Changes in eGFR
Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.
Adverse event collection and assessment
Adverse Event collection and assessment will be done for all treated subjects.
Secondary Outcome Measures
Profile of Pharmacokinetics
Relationship between the study drug dose and the trough concentration of study drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01574365
Brief Title
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
Official Title
A Phase 2 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 (undefined)
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 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.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RTA402
Arm Type
Experimental
Arm Title
RTA402 Low
Arm Type
Experimental
Arm Title
RTA402 Medium-low
Arm Type
Experimental
Arm Title
RTA402 Medium-high
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RTA 402
Primary Outcome Measure Information:
Title
Efficacy:Changes in eGFR
Description
Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.
Time Frame
Up to 16 weeks
Title
Adverse event collection and assessment
Description
Adverse Event collection and assessment will be done for all treated subjects.
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Profile of Pharmacokinetics
Description
Relationship between the study drug dose and the trough concentration of study drug
Time Frame
Baseline, week 4, 8 and 12.
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 etc.
Facility Information:
City
Toride City
State/Province
Ibaraki
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
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