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rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation

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ClinicalTrials.gov Identifier: NCT01207141
Recruitment Status : Active, not recruiting
First Posted : September 22, 2010
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Liver Transplantation Thymoglobulin Rejection

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 110 participants
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
Study Start Date : August 2006
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Groups and 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.

Outcome Measures

Primary Outcome Measures :
  1. Incidence and severity of biopsy-proven acute cellular rejection [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Time to Tacrolimus whole blood concentrations <8 ng/ml [ Time Frame: 1 year ]
  2. Duration of steroid treatment and time to steroid elimination [ Time Frame: 1 year ]

Biospecimen Retention:   None Retained

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 0- 21 years receiving liver transplantation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207141

United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Rakesh Sindhi, MD Children's Hospital of Pittsburgh of UPMC
More Information

Responsible Party: Rakesh Sindhi, Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01207141     History of Changes
Other Study ID Numbers: 0608006
1R01AI073895-01 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Rakesh Sindhi, University of Pittsburgh:
Liver Transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action