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A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574365
Recruitment Status : Terminated
First Posted : April 10, 2012
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Study Description
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Brief Summary:
A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Type 2 Diabetes Drug: RTA 402 Phase 2

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Adverse event collection and assessment [ Time Frame: Up to 16 weeks ]
    Adverse Event collection and assessment will be done for all treated subjects.


Secondary Outcome Measures :
  1. Profile of Pharmacokinetics [ Time Frame: Baseline, week 4, 8 and 12. ]
    Relationship between the study drug dose and the trough concentration of study drug


Eligibility Criteria
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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Japan
Toride City, Ibaraki, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
More Information
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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
Keywords provided by Kyowa Kirin Co., Ltd.:
CKD patients with type 2 diabetes
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency