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Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarpogrelate | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anplag(Sarpogrelate) | Drug | Sarpogrelate 100mg 2 tablets, bid, 400mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ACR(Urine Albumin/Creatinine ratio) | change of percentage | treatment period(24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| ACR(Urine Albumin/Creatinine ratio) | improvement efficiency rate of ACR comparing to baseline Definition of improvement efficiency : ACR become normal(<20mg/g Cr) or ACR is decreased more than 50% comparing to data before taking IP(Investigators' product) | Treatment period(24 weeks) |
| urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D.S Choi, MD, PhD | Korea University Hospital, Anam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University, Anam | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224730 | Derived | Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo |
| Drug |
Placebo 100mg 2 tablets, bid, 400mg/day |
|
changes comparing to baseline data |
| treatment period(24 weeks) |
| ACR(Urine Albumin/Creatinine ratio) | improved amount comparing to baseline data | treatment period(24 weeks) |
| ACR(Urine Albumin/Creatinine ratio) | rate of normalized ACR | treatment period(24 weeks) |
| Creatinine | improved amount of Creatinine | treatment period(24 weeks) |
| PCR(Protein to Creatinine ratio in Urine) | improved rate comparing to baseline data | treatment period(24 weeks) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |