Phase III Study of Treprostinil Infusion to Reduce Kidney Injury After Deceased Donor Kidney Transplantation in Adults

What this Trial Is About

Researchers are evaluating the preliminary safety and effectiveness of treprostinil, a prostacyclin analog, in reducing ischemia-reperfusion injury in adults receiving a deceased donor kidney transplant. This study focuses on kidney transplant patients aged 18 to 65 and aims to assess whether treprostinil can help restore blood flow to the new kidney and reduce graft dysfunction after transplantation. Treprostinil will be given through an intravenous infusion starting about 2 to 3 hours before the kidney transplant surgery and continuing for approximately 48 hours after surgery. The dose is gradually increased until reaching a target dose or until side effects require stopping the medication. Participants will be hospitalized and closely monitored during this two-day treatment phase. Participants will undergo intensive monitoring including blood tests to measure serum creatinine from day 1 to 7, along with other assessments such as INR, urine output, and evaluation for kidney function outcomes up to 30 days post-transplant. Safety and tolerability will also be observed throughout the treatment period. The total participation duration includes hospitalization for the treatment phase and follow-up assessments as specified in the study timeline.

Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation