Using Treprostinil to Reduce Kidney Injury During Transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of treprostinil, a prostacyclin analog, in minimizing ischemia-reperfusion injury in adult patients undergoing deceased donor kidney transplantation. Participants will receive a two-day intravenous infusion of treprostinil starting a few hours before the transplant and continuing for 48 hours post-surgery. The study will involve close monitoring of approximately 20 patients to assess the drug's impact on kidney graft function and recovery. The goal is to improve blood flow restoration to the transplanted kidney and reduce the risk of delayed graft function.

Why it matters

Who can join: the full rules

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

Where it's running

• Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting

Study contacts

• Study coordinator: George Bayliss, MD
• Email: gbayliss@Lifespan.org
• Phone: 401-444-8562

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.