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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02345057
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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).


Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: CS-3150 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: CS-3150
Drug: placebo
Experimental: CS-3150 1.25 mg
Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast.
Drug: CS-3150
Experimental: 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.
Drug: CS-3150
Drug: placebo
Experimental: CS-3150 5.0 mg
Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast
Drug: CS-3150
Placebo Comparator: Placebo
Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
Drug: placebo



Primary Outcome Measures :
  1. Change from baseline in urinary albumin to creatine ratio (UACR) [ Time Frame: Baseline to end of Week 12 ]

Secondary Outcome Measures :
  1. Transition from microalbuminuria to normoalbuminuria [ Time Frame: Baseline to end of Week 12 ]
  2. Change in renal function [ Time Frame: Baseline to end of Week 12 ]
  3. Change in serum potassium [ Time Frame: Baseline to end of Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345057


Locations
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Japan
Kumamoto, Japan, 862-0976
Sponsors and Collaborators
Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02345057     History of Changes
Other Study ID Numbers: CS3150-B-J204
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/daiichi-sankyo/

Keywords provided by Daiichi Sankyo, Inc.:
Diabetic Nephropathy
mineralocorticoid receptor antagonist
CS-3150
Japanese

Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents