Actively Recruiting
Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
Led by Rhode Island Hospital · Updated on 2026-04-23
20
Participants Needed
1
Research Sites
398 weeks
Total Duration
On this page
Sponsors
R
Rhode Island Hospital
Lead Sponsor
U
University of Rhode Island
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 to 65 years who will receive a deceased donor kidney and are on the active transplant list at RIH
- Documentation of a diabetes diagnosis or consistent clinical features
- Written informed consent obtained and ability to comply with study requirements
You will not qualify if you...
- Under 18 years of age
- Difficult venous access
- Body mass index over 40 kg/m2
- Severe clinical gastroparesis with repeated vomiting
- Prior gastrointestinal surgery except cholecystectomy, appendectomy, or Nissen fundoplication
- Known or history of inflammatory bowel disease or bezoars
- History of diverticulitis, diverticular stricture, or other intestinal strictures
- Receiving any investigational drug other than treprostinil or participating in another investigational study
- Receiving prostanoid therapy for portopulmonary hypertension
- Known hypersensitivity to prostaglandins, prostacyclin, or treprostinil
- Failed kidney transplant within the previous 180 days
- Receiving non-standard immunosuppression or treatment affecting study interpretation
- Significant cardiovascular disease including treatment with inotropes
- Female who is pregnant or nursing
- Any condition or abnormality that compromises patient safety or data quality as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
G
George Bayliss, MD
CONTACT
N
Nisanne Ghonem, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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