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A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

This study has been terminated.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd Identifier:
First received: April 4, 2012
Last updated: February 28, 2017
Last verified: February 2017
A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

Condition Intervention Phase
Chronic Kidney Disease
Type 2 Diabetes
Drug: RTA 402
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2 GFR Measuring Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Efficacy: glomerular filtration rate measured by inulin clearance [ Time Frame: Up to 16 weeks ]
    Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated.

  • Adverse Event collection and assessment [ Time Frame: Up to 16 weeks ]
    Adverse Event collection

Enrollment: 11
Actual Study Start Date: February 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RTA 402 Drug: RTA 402
once a day, oral administration

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.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
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
  • Patients for whom Inulead® injection is contraindicated etc.
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Please refer to this study by its identifier: NCT01572610

Koga city, Ibaraki, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT01572610     History of Changes
Other Study ID Numbers: RTA 402-004
Study First Received: April 4, 2012
Last Updated: February 28, 2017

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
CKD patients with type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency processed this record on April 28, 2017