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

NCT ID: NCT01574365

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Kidney Disease Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RTA402

Group Type EXPERIMENTAL

RTA 402

Intervention Type DRUG

RTA402 Low

Group Type EXPERIMENTAL

RTA 402

Intervention Type DRUG

RTA402 Medium-low

Group Type EXPERIMENTAL

RTA 402

Intervention Type DRUG

RTA402 Medium-high

Group Type EXPERIMENTAL

RTA 402

Intervention Type DRUG

Interventions

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RTA 402

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Toride, Ibaraki, Japan

Site Status

Countries

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Japan

Other Identifiers

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RTA 402-003

Identifier Type: -

Identifier Source: org_study_id

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