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

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Type 2 Diabetes Mellitus and Microalbuminuria

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02345057

Enrollment

365

Registered

2015-01-26

Start date

2015-01-31

Completion date

2016-07-31

Last updated

2018-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

Diabetic Nephropathy, mineralocorticoid receptor antagonist, CS-3150, Japanese

Brief summary

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).

Interventions

DRUGCS-3150

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in urinary albumin to creatine ratio (UACR)	Baseline to end of Week 12

Secondary

Measure	Time frame
Transition from microalbuminuria to normoalbuminuria	Baseline to end of Week 12
Change in renal function	Baseline to end of Week 12
Change in serum potassium	Baseline to end of Week 12

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026