Phase 2 N=40 Treatment

Budesonide for Liver Transplant Immune Suppression

Acute Cellular Graft Rejection · New Onset Diabetes After Transplant

Bottom Line

View on ClinicalTrials.gov: NCT03304626 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Jul 2021

Primary outcome: Primary: Number of Participants With Acute Cellular Rejection Between Study and Control Groups — 1; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Budesonide 3Mg Capsule (Drug); Standard of Care Prednisone (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Acute Cellular Rejection Between Study and Control Groups	1; 1	—
SECONDARY Rate of New Onset Diabetes After Transplant	0; 3	—
SECONDARY Number of Participants With Adrenal Suppression	2	—
SECONDARY Number of Participants With Adverse Events	10; 6	—

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 is rates of acute cellular rejection within first 24 weeks post-liver transplant. Secondary end points include rates of new onset diabetes after transplant and safety of budesonide. The study is structured as a prospective clinical trial. After receiving 4 days of intravenous corticosteroids on liver transplant post-operative days 0 through 3, subjects will be started on standard immunosuppression plus enteric coated budesonide (study drug) in place of standard immune suppression plus prednisone (standard of care). Study drug will be tapered over 12 weeks in accordance with the existing standard of care immune suppression protocol. Subjects will be followed in outpatient transplant clinic for 24 weeks. The purpose of the study is to conduct a pilot study to generate rates and effect size that can be used in a subsequent equivalent trial. A total of 20 subjects will be enrolled to receive the standard immunosuppression plus budesonide and their outcomes will be compared to 20 controls receiving standard immunosuppression plus prednisone (standard of care). The use of controls is to generate rate and variability that can be compared with the rate obtained from patients that receive study drug by examining the 95% confidence band.

Eligibility Criteria

Inclusion Criteria

Female or male subjects aged 21-75 years old
Received a primary liver transplant within 4 days of enrollment

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03304626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.