Using Treprostinil to Reduce Kidney Injury During Transplantation
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
PHASE1; PHASE2 · Rhode Island Hospital · NCT04005469
This study is testing if a medication called treprostinil can help protect the kidneys of adults getting a transplant from deceased donors and improve their recovery.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Rhode Island Hospital (other) |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT04005469 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are on the active transplant list for a deceased donor kidney and have a documented diagnosis of diabetes.
Not a fit: Patients under 18 years old, those with difficult venous access, or a BMI over 40 kg/m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney transplant outcomes and reduce the incidence of delayed graft function.
How similar studies have performed: While the use of treprostinil in this specific context is novel, similar approaches targeting ischemia-reperfusion injury have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Study coordinator: George Bayliss, MD
- Email: gbayliss@Lifespan.org
- Phone: 401-444-8562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemia Reperfusion Injury, Delayed Graft Function, Ischemia-reperfusion injury, kidney transplantation, prostacyclin, treprostinil, delayed graft function