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

February 28, 2017 updated by: Kyowa Kirin Co., Ltd.

A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Ibaraki
      • Toride City, Ibaraki, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 16 weeks
Adverse event collection and assessment
Time Frame: Up to 16 weeks
Adverse Event collection and assessment will be done for all treated subjects.
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of Pharmacokinetics
Time Frame: Baseline, week 4, 8 and 12.
Relationship between the study drug dose and the trough concentration of study drug
Baseline, week 4, 8 and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (ESTIMATE)

April 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTA 402-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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