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 complications often observed in the OLT population. This study is intended to investigate the therapeutic potential of this ISP combination.
Brief Title
Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects
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 comparison to standard ISP (S-ISP). Subjects will include OLT patients age 18 years and older receiving their first single-organ living- or deceased-donor liver transplant. Subjects must have post-operative recovery of graft function and be able to take oral medications before beginning treatment according to the study protocol.
Subjects will be randomized to receive either (1) investigational oral ISP including budesonide 9mg by mouth in three daily divided doses, FK with an initial target trough level of no greater than 5-6ng/mL, and MMF (I-ISP); or (2) S-ISP including prednisone, calcineurin antagonist, and MMF. After randomization, subjects will be followed for a total of 52 weeks and assessed for adequacy of graft function, and complications of therapy, particularly ACR
Subjects will be randomized to receive either (1) investigational oral ISP including budesonide 9mg by mouth in three daily divided doses, FK with an initial target trough level of no greater than 5-6ng/mL, and MMF (I-ISP); or (2) S-ISP including prednisone, calcineurin antagonist, and MMF. After randomization, subjects will be followed for a total of 52 weeks and assessed for adequacy of graft function, and complications of therapy, particularly ACR
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Acute Cellular Graft Rejection
Liver Transplant Rejection
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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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Exclusion Criteria: 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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Inclusion Criteria
Inclusion Criteria: 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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Gender
All
Gender Based
false
Keywords
Graft loss
Renal failure
Infection
Diabetes
Hypertension
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03315052
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-7959
Overall Status
Withdrawn
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Budesonide in Liver Transplantation
Primary Outcomes
Outcome Description
Incidence of ACR in budesonide treatment arm as compared to standard treatment arm
Outcome Measure
Acute cellular rejection (ACR)
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Description
Cumulative average trough level of tacrolimus in budesonide and standard treatment arms
Outcome Time Frame
12 months
Outcome Measure
Tacrolimus trough levels
Outcome Description
Incidence of diabetes in in budesonide and standard treatment arms
Outcome Time Frame
12 months
Outcome Measure
Diabetes
Outcome Description
Incidence of worsening kidney function in budesonide and standard treatment arms
Outcome Time Frame
12 months
Outcome Measure
Worsening kidney function
Outcome Description
Incidence of hypertension in in budesonide and standard treatment arms
Outcome Time Frame
12 months
Outcome Measure
Hyptertension
Outcome Description
Graft survival in budesonide and standard treatment arms
Outcome Time Frame
12 months
Outcome Measure
Graft survival
Outcome Description
Patient survival in budesonide and standard treatment arms
Outcome Time Frame
12 months
Outcome Measure
Patient survival
Outcome Description
Incidence of infection in budesonide and standard treatment arms
Outcome Time Frame
12 months
Outcome Measure
Infection
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
John Reinus
Investigator Email
jreinus@montefiore.org
Investigator Phone