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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01572610
First received: April 4, 2012
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 Company, Limited:

Primary Outcome Measures:
  • Efficacy: glomerular filtration rate measured by inulin clearance [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Adverse Event collection


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Primary Completion Date: December 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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
  • Patients for whom Inulead® injection is contraindicated etc.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572610

Locations
Japan
Koga city, Ibaraki, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01572610     History of Changes
Other Study ID Numbers: RTA 402-004
Study First Received: April 4, 2012
Last Updated: March 26, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
CKD patients with type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 17, 2014