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Study identifier: NCT04005469 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Ischemia Reperfusion Injury · Delayed Graft Function  ·  Sponsor: Rhode Island Hospital

PhasePhase 1/Phase 2
Planned participants20
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

George Bayliss, MD  ·  401-444-8562  ·  gbayliss@Lifespan.org

Nisanne Ghonem, PharmD, PhD  ·  401-874-4805  ·  nghonem@uri.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Rhode Island HospitalProvidence, Rhode Island, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04005469