| Trial ID: | L1090 |
| Source ID: | NCT01574365
|
| Associated Drug: |
Rta 402
|
| Title: |
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Type 2 Diabetes
|
| Interventions: |
DRUG: RTA 402
|
| Outcome Measures: |
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|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.
|
| Sponsor/Collaborators: |
Sponsor: Kyowa Kirin Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
53
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-02
|
| Completion Date: |
2013-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-03
|
| Locations: |
Toride City, Ibaraki, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01574365
|
