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OpenTrials
Completed

NCT Number: NCT02877628

Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation

Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Rennes

Rennes, 35033, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults over 18
  • Liver transplant recipients
  • Treated with an immunosuppressive protocol with tacrolimus
  • Informed on the study and who did not refuse to participate

Exclusion criteria

  • Patients who participate in a study with procedures incompatible with the present study.
  • Patients with legal protection/deprived of liberty.

Treatment and study plan

Pharmacokinetic-pharmacodynamic model in liver transplantation

Other

Biological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination

Primary outcomes

  1. Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

    Time frame: Week 24

    Assessement of the relationships between tacrolimus dosage, whole-blood and intracellular concentrations

  2. Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

    Time frame: Week 24

    Assessement of the relationships between intracellular concentrations of tacrolimus and calcineurin activity

  3. Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

    Time frame: Week 24

    Assessement of the relationships between donor and recipient CYP3A5 and ABCB1 genotypes and dose/concentration of tacrolimus

  4. Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

    Time frame: Week 24

    Assessement of the relationships between intracellular concentration of tacrolimus and/or calcineurin activity and ACR, in patients treated with immediate release or modified-release formulation of tacrolimus

Secondary outcomes

  1. Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration

    Time frame: Week 24

  2. Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR)

    Time frame: Week 24

  3. Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release)

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: OPTILTH

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2016
Registry last updated
Jan 28, 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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