A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01574365 |
Recruitment Status :
Terminated
First Posted : April 10, 2012
Last Update Posted : March 3, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease Type 2 Diabetes | Drug: RTA 402 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: RTA402 |
Drug: RTA 402 |
Experimental: RTA402 Low |
Drug: RTA 402 |
Experimental: RTA402 Medium-low |
Drug: RTA 402 |
Experimental: RTA402 Medium-high |
Drug: RTA 402 |
- Efficacy:Changes in eGFR [ Time Frame: Up to 16 weeks ]Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.
- Adverse event collection and assessment [ Time Frame: Up to 16 weeks ]Adverse Event collection and assessment will be done for all treated subjects.
- Profile of Pharmacokinetics [ Time Frame: Baseline, week 4, 8 and 12. ]Relationship between the study drug dose and the trough concentration of study drug

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Ages Eligible for Study: | 20 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574365
Japan | |
Toride City, Ibaraki, Japan |
Responsible Party: | Kyowa Kirin Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01574365 |
Other Study ID Numbers: |
RTA 402-003 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | March 3, 2017 |
Last Verified: | February 2017 |
CKD patients with type 2 diabetes |
Kidney Diseases Renal Insufficiency, Chronic Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency |