RECRUITING

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

Conditions

Ischemia Reperfusion Injury Delayed Graft Function Ischemia-reperfusion injury kidney transplantation prostacyclin treprostinil

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2020-11-13

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04005469

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Reginald Y Gohh, MD

CONTACT

401-444-3284

RGohh@Lifespan.org

Nisanne Ghonem, PharmD, PhD

CONTACT

401-874-4805

nghonem@uri.edu

Study Locations (Sites)

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-13

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2020-11-13

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

Ischemia-reperfusion injury
kidney transplantation
prostacyclin
treprostinil
delayed graft function

Additional Relevant MeSH Terms

Ischemia Reperfusion Injury
Delayed Graft Function