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

Last updated: July 18, 2023
Sponsor: Rhode Island Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Organ Transplant

Occlusions

Treatment

Treprostinil

Clinical Study ID

NCT04005469
974570-5
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  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 featuresconsistent will be noted for all patients.
  3. Written informed consent (and assent when applicable) obtained from subject orsubject's legal representative and ability for subject to comply with the requirementsof the study.

Exclusion

Exclusion Criteria:

  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 anyother investigational study
  9. Be receiving any prostanoid therapy to treat portopulmonary hypertension
  10. Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil
  11. Have had a failed kidney transplant within the previous 180 days
  12. Be receiving any non-standard immunosuppression protocol or other non-standardtreatment that could affect interpretation of the study results
  13. Those with significant cardiovascular disease including treatment with inotropes
  14. If female, be pregnant or nursing (confirmed by urine test)
  15. Presence of a condition or abnormality that in the opinion of the Investigators thatwould compromise the safety of the patient or the quality of the data

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Treprostinil
Phase: 1/2
Study Start date:
November 13, 2020
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

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