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| Name | Class |
|---|---|
| University of Rhode Island | OTHER |
| United Therapeutics | INDUSTRY |
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The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate the restoration of blood supply to the revascularized kidney graft via its vasodilatory actions, well characterized protective effects, and longer elimination half-life. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trepostinil | Experimental | Treprostinil (Remodulin) will be administered IV by a standard 3 + 3 dose-escalation approach. This dosing model will be followed until a target dose of 15 mg/kg/min is achieved or if it is medically determined that side effects prevent dose escalation. IV infusion will commence approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of surgery, unless hemodynamic changes or tolerability require discontinuation of treprostinil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treprostinil | Drug | Treprostinil (Remodulin) will be administered IV by a standard 3 + 3 dose-escalation approach. This dosing model will be followed until a target dose of 15 mg/kg/min is achieved or if it is medically determined that side effects prevent dose escalation. IV infusion will commence approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of surgery, unless hemodynamic changes or tolerability require discontinuation of treprostinil. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine (SCr) | Primary efficacy assessment will include the cGFR using SCr during the first seven days post transplantation. | Day 1-7 |
| Measure | Description | Time Frame |
|---|---|---|
| INR | biochemical end point | Day 7 |
| Urine output | biochemical end point | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Bayliss, MD | Contact | 401-444-8562 | gbayliss@Lifespan.org | |
| Nisanne Ghonem, PharmD, PhD | Contact | 401-874-4805 | nghonem@uri.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
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Treprostinil will be administered intravenously by a standard 3 + 3 dose-escalation approach. The first three patients will receive a starting rate of 1.25 ng/kg/min and if all three patients safely tolerate the first dose, the next three patients will receive a dose of 2.5 ng/kg/min. If any patients experience side effects, additional patients will receive the previous lower dose. This dosing model will be followed until a target dose of 15 mg/kg/min is achieved or if it is medically determined that side effects prevent dose escalation.
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| Primary graft non-function; kidney failure | dialysis, death or re-transplantation | Day 30 |
| Delayed graft function | use of dialysis | Day 30 |
| D013568 | Pathological Conditions, Signs and Symptoms |