Recruiting
Phase 1
Phase 2

Treprostinil

Sponsor:

Rhode Island Hospital

Code:

NCT04005469

Conditions

Ischemia Reperfusion Injury

Delayed Graft Function

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Treprostinil

Study Details

Brief 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.

Conditions

Ischemia Reperfusion Injury

Delayed Graft Function

Study ID

NCT04005469

Start date

Nov 13, 2020

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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.

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 any other 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-standard treatment 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 that would compromise the safety of the patient or the quality of the data

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Trepostinil

Treprostinil (Remodulin) will be administered IV by a standard 3 + 3 dose-escalation approach. This dosing model will be followed until a target dose of 15 mg/kg/min is achieved or if it is medically determined that side effects prevent dose escalation. IV infusion will commence approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of surgery, unless hemodynamic changes or tolerability require discontinuation of treprostinil.

Interventions

Treprostinil

Treprostinil (Remodulin) will be administered IV by a standard 3 + 3 dose-escalation approach. This dosing model will be followed until a target dose of 15 mg/kg/min is achieved or if it is medically determined that side effects prevent dose escalation. IV infusion will commence approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of surgery, unless hemodynamic changes or tolerability require discontinuation of treprostinil.

Primary outcome measure

  • Serum creatinine (SCr) [ Time Frame: Day 1-7 ]

Central Contacts and Locations

Central contacts

George Bayliss, MD

401-444-8562gbayliss@Lifespan.org

Nisanne Ghonem, PharmD, PhD

401-874-4805nghonem@uri.edu

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

George Bayliss, MD

401-444-8562gbayliss@Lifespan.org

Nisanne Ghonem, PharmD, PhD

401-874-4805nghonem@uri.edu

More Information

Sponsor

Rhode Island Hospital

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Ischemia-reperfusion injury
  • kidney transplantation
  • prostacyclin
  • treprostinil
  • delayed graft function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-04-23.