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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV120027 | Experimental | TRV120027 administered as an IV infusion |
|
| Normal Saline | Placebo Comparator | Normal Saline administered as an IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV120027 | Drug | IV infusion |
| |
| Normal Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Glomerular Filtration Rate | Assessments of glomerular filtration rate are made hourly during the 6-hour study drug infusion on study Day 1 and study Day 3. GFR in hours 4-6 are compared to GFR in hours 1-3, and comparisons made between Placebo and TRV120027. | Every hour during final 6 hours of study drug infusion |
| Change from Baseline in Vital Signs (Blood pressure, heart rate) | Vital signs measurements made during and following drug infusion will be evaluated as a change from baseline, and comparing placebo to TRV120027. Assessments are made on study Day 1 and study Day 3. | Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States | ||
| DaVita Clinical Research |
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| Label | URL |
|---|---|
| Sponsor's Website | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C555534 | Sar-Arg-Val-Tyr-Ile-His-Pro-Ala-OH |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
IV infusion |
|
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| Duke Clinical Research Unit | Durham | North Carolina | 27705 | United States |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |