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

NCT02345057 | Completed Phase 2 DMC

• 1 other identifier: CS3150-B-J204
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Nephropathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in urinary albumin to creatine ratio (UACR)

  Baseline to end of Week 12

Secondary Outcomes (3)

• 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

Study Arms (5)

CS-3150 0.625 mg

EXPERIMENTAL

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

Drug: CS-3150; Drug: placebo

CS-3150 1.25 mg

EXPERIMENTAL

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

Drug: CS-3150

CS-3150 2.5 mg

EXPERIMENTAL

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

Drug: CS-3150; Drug: placebo

CS-3150 5.0 mg

EXPERIMENTAL

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

Drug: CS-3150

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

CS-3150 DRUG

CS-3150 0.625 mg; CS-3150 1.25 mg; CS-3150 2.5 mg; CS-3150 5.0 mg

placebo DRUG

CS-3150 0.625 mg; CS-3150 2.5 mg; Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Unknown Facility

Kumamoto, 862-0976, Japan

Location

Related Publications (1)

• 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.

  PMID: 33107592 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

esaxerenone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 21, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (1)