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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Exprimental (TRK-100STP) | Experimental | high dose |
|
| 2: Exprimental (TRK-100STP) | Experimental | low dose |
|
| 3: Placebo Comparator | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beraprost | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time | 50 weeks (Run-in 22weeks, Treatment 28 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26475266 | Derived | Koyama A, Fujita T, Gejyo F, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial. BMC Nephrol. 2015 Oct 16;16:165. doi: 10.1186/s12882-015-0130-5. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| D009400 | Nephrosclerosis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C048081 | beraprost |
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| Drug |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |