Status:
COMPLETED
Budesonide for Liver Transplant Immune Suppression
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
American College of Gastroenterology
Conditions:
Acute Cellular Graft Rejection
New Onset Diabetes After Transplant
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
This is a pilot study that investigates the efficacy and safety of budesonide as an immune suppressing agent for liver transplant recipients in the early post-transplant period. The primary end-point...
Detailed Description
Enrollment of Subjects: All consecutive patients undergoing liver transplant (LT) at the University Of Cincinnati Transplant Center will be screened for enrollment upon admission for transplant surger...
Eligibility Criteria
Inclusion
- Female or male subjects aged 21-75 years old
- Received a primary liver transplant within 4 days of enrollment
Exclusion
- Received previous organ transplants
- Undergoing multiple organ transplants
- Recipients with advanced fibrosis in graft
- Treatment plan for subject includes receiving immunosuppressant therapy other than standard immune suppression (SIS) as per University of Cincinnati LT immune suppression protocol (UC-ISP).
- Inability to take enteral (orally or by tube feed) medications by day 4 post-transplant
- Subjects with diabetes mellitus prior to transplant (diabetes mellitus defined as use of hypoglycemic agents or HbA1c \> 6.4 prior to transplant)
- Subjects who have any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation.
- Subjects who have been exposed to an investigational therapy within 30 days prior to enrollment or 5 half-lives on the investigational product, whichever is greater.
- Subjects in which concomitant use of medications which are inhibitors of CYP3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin) cannot be avoided during the study period.
- Pregnant females
- Diminished mental capacity to consent for the study as determined by attending on the record.
Key Trial Info
Start Date :
June 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03304626
Start Date
June 27 2017
End Date
December 31 2019
Last Update
July 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219