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NCT Number: NCT04005469

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

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.

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Key information

Conditions

Ischemia Reperfusion Injury Cardiovascular Diseases Delayed Graft Function Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients.
  • 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

  • Under the age of 18 years
  • Difficult venous access
  • BMI > 40 kg/m2
  • Patients with severe clinical gastroparesis as determined by repeated vomiting
  • Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
  • Known or history of inflammatory bowel disease or bezoars
  • History of diverticulitis, diverticular stricture, and other intestinal strictures
  • Be receiving any investigational drug other than treprostinil or participating in any other investigational study
  • Be receiving any prostanoid therapy to treat portopulmonary hypertension
  • Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil
  • Have had a failed kidney transplant within the previous 180 days
  • Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results
  • Those with significant cardiovascular disease including treatment with inotropes
  • If female, be pregnant or nursing (confirmed by urine test)
  • 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

Treatment and study plan

Treprostinil

Drug

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.

Other names: Remodulin®

Primary outcomes

  1. Serum creatinine (SCr)

    Time frame: Day 1-7

    Primary efficacy assessment will include the cGFR using SCr during the first seven days post transplantation.

Secondary outcomes

  1. INR

    Time frame: Day 7

    biochemical end point

  2. Urine output

    Time frame: Day 7

    biochemical end point

  3. Primary graft non-function; kidney failure

    Time frame: Day 30

    dialysis, death or re-transplantation

  4. Delayed graft function

    Time frame: Day 30

    use of dialysis

Study contacts

Contact information is provided by the study sponsor or research team.

George Bayliss, MD

CONTACT

[email protected]

401-444-8562

Nisanne Ghonem, PharmD, PhD

CONTACT

[email protected]

401-874-4805

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • United Therapeutics
  • University of Rhode Island

Registry information

Official study title

A Phase I/II Study Evaluating the Preliminary Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During De Novo Adult Kidney Transplantation

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jul 2, 2019
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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