A Pilot Trial of Pediatric Liver Transplantation Without Steroids

Evidence of Liver Transplantation Clinical Trial

Official title:

A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00694408
• Other study ID #: SFPT/OL
• Status: Terminated
• Phase: Phase 3
• First received: June 6, 2008
• Last updated: January 19, 2017
• Start date: June 2008
• Est. completion date: August 2011

Study information

• Verified date: January 2017
• Source: Birmingham Children's Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective:

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.

Description:

3.2 Research question

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children undergoing primary isolated hepatic transplantation.

• Age <=18 years

• Ability to provide informed consent

Exclusion Criteria:

• Children undergoing retransplantation.

• 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.

Related Conditions & MeSH terms

• Evidence of Liver Transplantation

Intervention

Drug:
• methyl prednisolone, hydrocortisone, prednisolone
Will be specific dependant on weight of patients

Other:
• No steroids
Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
Birmingham Children's Hospital NHS Foundation Trust	Roche Pharma AG

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

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. — View Citation

Evans HM, McKiernan PJ, Kelly DA. Mycophenolate mofetil for renal dysfunction after pediatric liver transplantation. Transplantation. 2005 Jun 15;79(11):1575-80. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Reding R, Gras J, Sokal E, Otte JB, Davies HF. Steroid-free liver transplantation in children. Lancet. 2003 Dec 20;362(9401):2068-70. — View Citation

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. — View Citation

Vidhun JR, Sarwal MM. Corticosteroid avoidance in pediatric renal transplantation. Pediatr Nephrol. 2005 Mar;20(3):418-26. Review. — View Citation

Walsh PT, Taylor DK, Turka LA. Tregs and transplantation tolerance. J Clin Invest. 2004 Nov;114(10):1398-403. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: The development of histologically proven acute rejection. (within 12 months		12m
Secondary	The development of steroid resistant acute rejection 12 months. The expression of tissue and circulating markers of immune tolerance in first year post transplant The incidence of infection in the first year post transplant		12m