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A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria

NCT ID: NCT02345057

Last Updated: 2018-12-21

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-07-31

Brief Summary

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This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria.

The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).

Detailed Description

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Conditions

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Diabetic Nephropathy

Keywords

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Diabetic Nephropathy mineralocorticoid receptor antagonist CS-3150 Japanese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CS-3150 0.625 mg

One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

placebo

Intervention Type DRUG

CS-3150 1.25 mg

Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast.

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

CS-3150 2.5 mg

One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

placebo

Intervention Type DRUG

CS-3150 5.0 mg

Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast

Group Type EXPERIMENTAL

CS-3150

Intervention Type DRUG

Placebo

Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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CS-3150

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes mellitus
* Male or female subjects aged 20 years or older at informed consent
* Subjects with urinary albumin to creatine ratio (UACR) ≥ 45 mg/g Cr and \< 300 mg/g Cr
* Estimated glomerular filtration rate by creatinine (eGFRcreat) ≥ 30 mL/min/1.73 m\^2
* Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 3 months prior to treatment period

Exclusion Criteria

* Type 1 diabetes
* HbA1c (NGSP) \>=8.4%
* Secondary glucose intolerance
* Subjects diagnosed with non-diabetic nephropathy
* Nephrotic syndrome
* Secondary hypertension or malignant hypertension
* Serum potassium level in any of the following categories: For subjects with eGFRcreat of ≥ 45 mL/min/1.73 m\^2, serum potassium level of \< 3.5 mEq/L or ≥ 5.1 mEq/L; For subjects with eGFRcreat of ≥ 30 mL/min/1.73 m\^2 and \< 45 mL/min/1.73 m\^2, serum potassium level of \< 3.5 mEq/L or ≥ 4.8 mEq/L
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kumamoto, , Japan

Site Status

Countries

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Japan

References

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Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

Reference Type DERIVED
PMID: 33107592 (View on PubMed)

Other Identifiers

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CS3150-B-J204

Identifier Type: -

Identifier Source: org_study_id