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rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01207141
First Posted: September 22, 2010
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Rakesh Sindhi, University of Pittsburgh
  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 Rakesh Sindhi, University of Pittsburgh:

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

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

Biospecimen Retention:   None Retained
Blood

Enrollment: 110
Study Start Date: August 2006
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

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
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
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


Locations
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)
Investigators
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 Submitted: September 21, 2010
First Posted: September 22, 2010
Last Update Posted: April 4, 2017
Last Verified: March 2017

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

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