Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| CS-3150 1.25 mg | Experimental | Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast. |
|
| 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. |
|
| CS-3150 5.0 mg | Experimental | Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast |
|
| Placebo | Placebo Comparator | Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-3150 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in urinary albumin to creatine ratio (UACR) | Baseline to end of Week 12 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kumamoto | 862-0976 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33107592 | Derived | 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. |
Not provided
Not provided
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/
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.
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.
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C000607547 | esaxerenone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Baseline to end of Week 12 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |