A Pilot Trial of Pediatric Liver Transplantation Without Steroids
NCT ID: NCT00694408
Last Updated: 2017-01-20
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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TERMINATED
PHASE3
15 participants
INTERVENTIONAL
2008-06-30
2011-08-31
Brief Summary
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The overall objective is to investigate whether a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation and whether it promotes tolerance.
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Detailed Description
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Is it possible to avoid the use of corticosteroids in pediatric liver transplantation?
3.3 Trial objectives
This will be a pilot study to
i) investigate to what degree a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation
ii) investigate the effect of a steroid free immunosuppressive regimen on lymphocyte function and donor-specific immune responsiveness following pediatric liver transplantation
iii) investigate the effect of a steroid free immunosuppressive regimen on expression of tissue markers of tolerance following pediatric liver transplantation
It is hoped that this pilot study will be used to develop a definitive multicentre study of a steroid free regimen.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Steroid immunosuppressive regimen
Freedom from rejection and safety in children undergoing paediatric liver transplant using steroid containing immunosuppression regimen post transplant. This group of patients will receive steroids in conjunction with other prescribed immunosuppressive agents. Intervention is use of methyl prednisolone, hydrocortisone, prednisolone as routine post transplant management
methyl prednisolone, hydrocortisone, prednisolone
Will be specific dependant on weight of patients
Steroid free immunosuppressive regimen
Freedom from rejection and safety in children undergoing paediatric liver transplant using steroid free immunosuppression regimen post transplant. The patients in this arm will receive immunosuppression but not steroids to compare with those treated with steroids to measure differences in rejection and safety of a steroid free immunosuppressive regimen. Intervention is omission of methyl prednisolone, hydrocortisone, prednisolone as routine post transplant management. No steroids will be used routinely in this arm
No steroids
Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol
Interventions
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methyl prednisolone, hydrocortisone, prednisolone
Will be specific dependant on weight of patients
No steroids
Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \<=18 years
* Ability to provide informed consent
Exclusion Criteria
* Transplantation for Intestinal failure associated liver disease.
* Multi-organ transplantation.
* Transplantation for autoimmune liver disease.
* Transplantation for extra hepatic malignancy.
* Pre-existing need for oral steroids, or high dose inhaled steroids sufficient to require a steroid warning card.
1 Day
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Birmingham Women's and Children's NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Patrick McKiernan, MRCP FRCPCH
Role: PRINCIPAL_INVESTIGATOR
Birmingham Children's Hospital
Locations
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Birmingham Children's Hospital
Birmingham, West Midlands, United Kingdom
Countries
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References
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Evans HM, McKiernan PJ, Kelly DA. Mycophenolate mofetil for renal dysfunction after pediatric liver transplantation. Transplantation. 2005 Jun 15;79(11):1575-80. doi: 10.1097/01.tp.0000163504.29054.3f.
Yoshizawa A, Ito A, Li Y, Koshiba T, Sakaguchi S, Wood KJ, Tanaka K. The roles of CD25+CD4+ regulatory T cells in operational tolerance after living donor liver transplantation. Transplant Proc. 2005 Jan-Feb;37(1):37-9. doi: 10.1016/j.transproceed.2004.12.259.
Hathaway M, Adams DH. Demonstration that donor-specific nonresponsiveness in human liver allograft recipients is both rare and transient. Transplantation. 2004 Apr 27;77(8):1246-52. doi: 10.1097/01.tp.0000121136.84965.35.
Walsh PT, Taylor DK, Turka LA. Tregs and transplantation tolerance. J Clin Invest. 2004 Nov;114(10):1398-403. doi: 10.1172/JCI23238.
Sarwal MM, Vidhun JR, Alexander SR, Satterwhite T, Millan M, Salvatierra O Jr. Continued superior outcomes with modification and lengthened follow-up of a steroid-avoidance pilot with extended daclizumab induction in pediatric renal transplantation. Transplantation. 2003 Nov 15;76(9):1331-9. doi: 10.1097/01.TP.0000092950.54184.67.
Vidhun JR, Sarwal MM. Corticosteroid avoidance in pediatric renal transplantation. Pediatr Nephrol. 2005 Mar;20(3):418-26. doi: 10.1007/s00467-004-1786-4. Epub 2005 Feb 3.
Leonard H, Hornung T, Parry G, Dark JH. Pediatric cardiac transplant: results using a steroid-free maintenance regimen. Pediatr Transplant. 2003 Feb;7(1):59-63. doi: 10.1034/j.1399-3046.2003.00014.x.
Arora-Gupta N, Davies P, McKiernan P, Kelly DA. The effect of long-term calcineurin inhibitor therapy on renal function in children after liver transplantation. Pediatr Transplant. 2004 Apr;8(2):145-50. doi: 10.1046/j.1399-3046.2003.00132.x.
Kelly D, Jara P, Rodeck B, Lykavieris P, Burdelski M, Becker M, Gridelli B, Boillot O, Manzanares J, Reding R. Tacrolimus and steroids versus ciclosporin microemulsion, steroids, and azathioprine in children undergoing liver transplantation: randomised European multicentre trial. Lancet. 2004 Sep 18-24;364(9439):1054-61. doi: 10.1016/S0140-6736(04)17060-8.
Reding R, Gras J, Sokal E, Otte JB, Davies HF. Steroid-free liver transplantation in children. Lancet. 2003 Dec 20;362(9401):2068-70. doi: 10.1016/S0140-6736(03)15104-5.
Other Identifiers
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SFPT/OL
Identifier Type: -
Identifier Source: org_study_id
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