Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects
NCT ID: NCT03315052
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2019-01-31
2022-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Budesonide treatment arm
Patients treated with budesonide in place of prednisone as part of immunosuppressive regimen
Budesonide
Oral steroid with high first-pass metabolism in liver
Tacrolimus（FK506）
Calcineurin immunosuppressant
Mycophenolate Mofetil
Immunosupressant
Standard immunosuppression arm
Patients treated with standard immunosuppression after liver transplant
Tacrolimus（FK506）
Calcineurin immunosuppressant
Mycophenolate Mofetil
Immunosupressant
Prednisone
Immunosuppresant
Interventions
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Budesonide
Oral steroid with high first-pass metabolism in liver
Tacrolimus（FK506）
Calcineurin immunosuppressant
Mycophenolate Mofetil
Immunosupressant
Prednisone
Immunosuppresant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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References
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Jonsson G, Astrom A, Andersson P. Budesonide is metabolized by cytochrome P450 3A (CYP3A) enzymes in human liver. Drug Metab Dispos. 1995 Jan;23(1):137-42.
Weber T, Kalbhenn T, Herrmann G, Hanisch E. Local immunosuppression with budesonide after liver transplantation in the rat: a preliminary histomorphological analysis. Transplantation. 1997 Sep 15;64(5):705-8. doi: 10.1097/00007890-199709150-00007.
Ozcay N, Fryer J, Grant D, Freeman D, Garcia B, Zhong R. Budesonide, a locally acting steroid, prevents graft rejection in a rat model of intestinal transplantation. Transplantation. 1997 May 15;63(9):1220-5. doi: 10.1097/00007890-199705150-00006.
Bhat M, Ghali P, Wong P, Marcus V, Michel R, Cantarovich M, Metrakos P, Deschenes M. Immunosuppression with budesonide for liver transplant recipients with severe infections. Liver Transpl. 2012 Feb;18(2):262-3. doi: 10.1002/lt.22453. No abstract available.
Lichtenstein GR, Travis S, Danese S, D'Haens G, Moro L, Jones R, Huang M, Ballard ED, Bagin R, Hardiman Y, Collazo R, Sandborn WJ. Budesonide MMX for the Induction of Remission of Mild to Moderate Ulcerative Colitis: A Pooled Safety Analysis. J Crohns Colitis. 2015 Sep;9(9):738-46. doi: 10.1093/ecco-jcc/jjv101. Epub 2015 Jun 20.
Manns MP, Woynarowski M, Kreisel W, Lurie Y, Rust C, Zuckerman E, Bahr MJ, Gunther R, Hultcrantz RW, Spengler U, Lohse AW, Szalay F, Farkkila M, Prols M, Strassburg CP; European AIH-BUC-Study Group. Budesonide induces remission more effectively than prednisone in a controlled trial of patients with autoimmune hepatitis. Gastroenterology. 2010 Oct;139(4):1198-206. doi: 10.1053/j.gastro.2010.06.046. Epub 2010 Jun 22.
Other Identifiers
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2017-7959
Identifier Type: -
Identifier Source: org_study_id
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