rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01207141
First received: September 21, 2010
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

This open-label clinical trial will evaluate the pharmacodynamics, pharmacogenomics and early efficacy and safety of steroid-free Tacrolimus (TAC) monotherapy and its minimization after induction with rabbit, anti-human thymocyte globulin (rATG, Genzyme, Cambridge, MA) in children and adults with pediatric liver transplantation. Eighty subjects (0-21 years) receiving liver transplantation will be enrolled. Incidence and severity of biopsy-proven acute cellular rejection (ACR) is a primary endpoint as well as time to Tacrolimus whole blood concentrations <8 ng/ml The expected incidence of ACR is 50% and is derived from a non-consecutive subject population (n=40) who received an identical regimen in IND 64555. This incidence is acceptable because the long term sequel of rejection reported with other allografts have not been observed in liver grafts during IND 64555. These risks are further negated by the unique regenerative capacity of the liver allograft. An OBSERVATIONAL arm is being included in this trial. Because the numbers of pediatric liver transplants (LTx) are small in any single center setting, no information is known about relative outcomes on a conventional protocol, in children receiving conventional protocol of steroids+Tacrolimus. The PURPOSE of this additional recruitment is OBSERVATIONAL, only. Therefore, these subjects will NOT be randomized. Rather, by studying all types of patients, the investigators hope to utilize maximally, all available subjects, to understand the relative place of monotherapeutic induction. In turn, this will be the basis for a follow-up comparative, randomized trial.


Condition
Liver Transplantation
Thymoglobulin
Rejection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacodynamics, Pharmacogenomics, and Preliminary Safety and Efficacy of rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Incidence and severity of biopsy-proven acute cellular rejection [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Tacrolimus whole blood concentrations <8 ng/ml [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Duration of steroid treatment and time to steroid elimination [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
rATG induction
Liver transplant recipients who receive induction with rATG prior to transplantation.
no rATG induction
Liver transplant recipients who do not receive rATG induction therapy prior to transplantation.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children 0- 21 years receiving liver transplantation

Criteria

Inclusion Criteria:

  • Age 0-21 years, male and female
  • Primary OLTx, Whole/segmental, cadaveric/live, Re-LTx, and LTx in the setting of a previous or simultaneous kidney transplant.
  • All children receiving the types of LTx described above, but on conventional immunosuppression, will be enrolled in an observational arm, with the same treatment and monitoring protocols.

Exclusion Criteria:

  • Multiorgan transplants (liver-intestine, liver intestine with stomach and other organs)
  • Documented non-compliance
  • Donor: Age >60, macrovesicular steatosis > 30%, Hepatitis C and B infections defined as anti-HCV antibody positive, and anti-Hepatitis B surface antigen or Hepatitis B core antibody positive, malignancy, cold ischemia time >16 hours
  • Children of child-bearing age receive pregnancy testing at the time of transplantation. Pregnancy is a contraindication to liver transplantation and therefore to enrollment in this clinical trial.
  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: NCT01207141

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Rakesh Sindhi, MD Children's Hospital of Pittsburgh of UPMC
  More Information

No publications provided

Responsible Party: Rakesh Sindhi, MD, Children's Hospital of Pittsburgh of UPMC
ClinicalTrials.gov Identifier: NCT01207141     History of Changes
Other Study ID Numbers: 0608006, 1R01AI073895-01
Study First Received: September 21, 2010
Last Updated: March 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Liver Transplantation
Thymoglobulin
Rejection

ClinicalTrials.gov processed this record on October 22, 2014