Status:
WITHDRAWN
Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects
Lead Sponsor:
Montefiore Medical Center
Conditions:
Acute Cellular Graft Rejection
Liver Transplant Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Our hypothesis is that budesonide will provide effective hepatic ISP that will replace prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and calcineurin-associated comp...
Detailed Description
This study will be a randomized, open-label non-inferiority trial to assess the efficacy, safety and tolerability of budesonide in combination with low-dose FK and standard-dose MMF as post-OLT ISP in...
Eligibility Criteria
Inclusion
- Adult patients age 18 years or older who undergo initial single-organ living- or deceased-donor liver-transplant surgery. Research participants are required to have satisfactory post-operative recovery of graft function and no post-operative renal-replacement therapy prior to starting medication according to protocol. They must also be able to take oral medications.
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Exclusion
- Patients will be excluded from the study if they are: (1) undergoing retransplantation; (2) have fulminant hepatic failure as an indication for liver transplantation; (3) have surgical complication(s) potentially affecting post-operative graft function (i.e., hepatic artery thrombosis); or have delayed initial recovery of graft function (primary non-function) requiring non-standard induction therapy. Furthermore, patients with a contraindication to budesonide (i.e., hypersensitivity) will not be included in the study
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Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03315052
Start Date
January 1 2019
End Date
January 1 2022
Last Update
September 23 2019
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