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

Launched by RHODE ISLAND HOSPITAL · Jun 28, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and effectiveness of a medication called treprostinil (Remodulin®) in reducing a problem known as ischemia-reperfusion injury during kidney transplants. This injury can occur when blood supply to the new kidney is restored after surgery, potentially leading to kidney dysfunction. The study will involve about 20 adult participants aged 18 to 65 who are on the waiting list for a deceased donor kidney transplant. Participants will receive treprostinil through an IV starting a few hours before the surgery and continuing for about two days afterward.

To participate, individuals must be scheduled for a kidney transplant and have a diagnosis of diabetes. However, some people may not be eligible, including those under 18, those with certain medical conditions, or those who have had a previous kidney transplant within the last six months. Throughout the trial, participants will be closely monitored to ensure their safety and to assess how well the treatment is working. This study aims to provide valuable insights into improving kidney transplant outcomes for patients in the future.

Gender

ALL

Eligibility criteria

• 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