A Pilot Trial of Pediatric Liver Transplantation Without Steroids

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Birmingham Children's Hospital NHS Foundation Trust.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by:

Birmingham Children's Hospital NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT00694408

First received: June 6, 2008

Last updated: June 9, 2008

Last verified: June 2008

History of Changes

Purpose

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.

Condition	Intervention	Phase
Transplantation	Drug: methyl prednisolone, hydrocortisone, prednisolone Other: No steroids	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Pilot Trial of a Steroid-Free Immunosuppressant Regimen in Pediatric Liver Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Hydrocortisone acetate Hydrocortisone Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Hydrocortisone sodium succinate Prednisolone phosphate Hydrocortisone cypionate Prednisolone sodium succinate Methylprednisolone sodium succinate Hydrocortisone butyrate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

U.S. FDA Resources

Further study details as provided by Birmingham Children's Hospital NHS Foundation Trust:

Primary Outcome Measures:

Primary endpoint: The development of histologically proven acute rejection. (within 12 months [ Time Frame: 12m ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: 12m ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	30
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Steroid containing immunosuppression regimen post paediatric liver transplant	Drug: methyl prednisolone, hydrocortisone, prednisolone Will be specific dependant on weight of patients Other Name: Methylprednisolone;Hydrocortisone;Prednisolone
2 Steroid free immunosuppression regimen following paediatric liver transplantation	Other: No steroids Other Name: No steroids

Detailed 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.

Eligibility


Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694408

Contacts


Contact: Patrick J McKiernan, MRCP FRCPCH	44-12-1333-8262	pat.mckiernan@bch.nhs.uk
Contact: Carla McKiernan, BSc	44-12-1333-8257	carla.lloyd@bch.nhs.uk

Locations


United Kingdom
Birmingham Children's Hospital	Not yet recruiting
Birmingham, West Midlands, United Kingdom, B4 6NH
Principal Investigator: Patrick McKiernan, MRCP FRCPCH

Sponsors and Collaborators

Birmingham Children's Hospital NHS Foundation Trust

Hoffmann-La Roche

Investigators


Principal Investigator:	Patrick McKiernan, MRCP FRCPCH	Birmingham Children's Hospital

More Information

Publications:

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.

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

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.

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

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.

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.

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.

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

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.

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


Responsible Party:	Mrs Carole Cummins, Birmingham Children's Hospital
ClinicalTrials.gov Identifier:	NCT00694408 History of Changes
Other Study ID Numbers:	SFPT/OL
Study First Received:	June 6, 2008
Last Updated:	June 9, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Birmingham Children's Hospital NHS Foundation Trust:


End stage liver disease Paediatric liver transplantation Steroid free immunosuppression

Additional relevant MeSH terms:


Cortisol succinate Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone-17-butyrate Methylprednisolone Methylprednisolone Hemisuccinate Methylprednisolone acetate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Antiemetics Antineoplastic Agents	Antineoplastic Agents, Hormonal Autonomic Agents Central Nervous System Agents Dermatologic Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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