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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.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01572610
First received: April 4, 2012
Last updated: April 27, 2014
Last verified: April 2014
  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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 27, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014