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Completed

NCT Number: NCT01655563

Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation

Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus through genetics will help in early attainment and maintenance of the correct dosage level in the early post-transplant period. This pilot dose-finding trial will help to determine a dosing strategy guided by genotypes and age for solid organ transplant recipients that will be further validated through a multi-centre trial as an immediate next step. The study hypothesizes that dosage levels determined through age and genotype will be attained faster and more accurately than the standard dosing procedures in the 14-days after the transplant. Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster recovery (tested through the kidneys' ability to clear creatine from the blood) and result in lower frequencies of adverse effects and rejection of the transplant.

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Key information

Conditions

Heart Transplantation Kidney Transplantation Liver Transplantation

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age < 18 years old
  • Assessed and/or listed for heart, kidney, liver transplantation
  • Planned oral or enteral maintenance immunosuppression with tacrolimus post transplant
  • Informed consent of legal guardian

Exclusion criteria

  • Contra-indications to oral or enteral tacrolimus
  • Co-morbidities that preclude standard dosing e.g. significant renal or hepatic insufficiency
  • Participation in other investigational drug trials within 30 days of study initiation

Treatment and study plan

Tacrolimus

Drug

Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5.

Other names: Prograf

Primary outcomes

  1. Time to Achieve Therapeutic Tacrolimus Drug Concentrations

    Time frame: From Baseline to 30 days post-dose

    The primary outcome (efficacy) was time to achieve therapeutic tacrolimus trough concentrations

  2. Time to Maintain Stable Therapeutic Trough Concentrations

    Time frame: From Baseline to 30 days post-dose

    Defined as two consecutive concentrations at least 48 hours apart in the therapeutic range without any changes in tacrolimus dose

Secondary outcomes

  1. Clinical Adverse Events

    Time frame: Over 30 days, +/- 3 days

    The effect of pharmacogenetic dosing of tacrolimus for 48 hours on the frequency clinical adverse effects over 30±3 days.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

A Pharmacogenetic Trial of Tacrolimus Dosing After Pediatric Transplantation

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2012
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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