Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
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.
Sponsor: Rhode Island Hospital
You may qualify if…
- ✓ 1. Male and female patients who will receive a deceased donor kidney aged 18 to 65 (inclusive) and are currently on the active transplant list at RIH.
- ✓ 2. Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients.
- ✓ 3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
You may not qualify if…
- ✕ 1. Under the age of 18 years
- ✕ 2. Difficult venous access
- ✕ 3. BMI \> 40 kg/m2
- ✕ 4. Patients with severe clinical gastroparesis as determined by repeated vomiting
- ✕ 5. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
- ✕ 6. Known or history of inflammatory bowel disease or bezoars
- ✕ 7. History of diverticulitis, diverticular stricture, and other intestinal strictures
- ✕ 8. Be receiving any investigational drug other than treprostinil or participating in any other investigational study
Where it's recruiting
Providence
Source: ClinicalTrials.gov · NCT04005469 · last updated 2026-04-23