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Completed

NCT Number: NCT02010320

Computer Guided Doing of Tacrolimus in Renal Transplantation

Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. The model will be prospective tested in a randomized clinical trial.

The hypothesis is that the computer model is superior to experienced transplant physicians in reaching and keeping the patients in the target range of tacrolimus.

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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Olso university hospital - Rikshospitalet

Oslo, 0424, Norway

About this study

Patients will be randomized to either computer or standard dosing strategies at time of transplantation or as early after transplantation as possible in case of deceased donor transplants.

For patients in the computer arm the model will calculate the dose with the highest probability to reach the specified concentration target.

For all concentrations a predictive error will be calculated and this will be the primary endpoint that the statistics will be calculated on.

All patients will be followed for between 8 to 12 weeks post-transplant, according to center praxis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • renal transplant recipients using tacrolimus as part of their immunosuppression
  • above 18 years
  • signed informed consent

Exclusion criteria

  • no specific

Treatment and study plan

Computer dosing

Other

Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates

Standard dose determination

Other

Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic

Primary outcomes

  1. Predictive error (Cpred-Cobs)

    Time frame: 8 to 12 weeks

    Predictive error will be calculated as the computer predicted concentration minus the measured concentration over the first 8 to 12 weeks post-transplant in the computer group. The calculations will be binned into weekly assessments.

  2. Reaching the target concentration

    Time frame: 8 to 12 weeks post-transplant

    In each arm the deviation of the observed concentration front he preset target concentration will be calculated for each measured concentration. The deviations will be compared between the two arms.

Other outcomes

  1. Influence of CYP3A5 genotyping

    Time frame: 8 to 12 weeks post-transplant

    The model will be run without any information about patients CYP3A5 genotype as this is not clinical praxis at our center yet. All patients will however be genotyped after the study and a model including this covariate will be used to recalculate the data and see if this model is superior to the simple model, primary by comparing predictive errors in the computer arm.

Sponsors and collaborators

Lead sponsor

University of Oslo School of Pharmacy

Other

Collaborators

  • Rikshospitalet University Hospital

Registry information

Official study title

Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients

Acronym: OPTIMAL

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2013
Registry last updated
Dec 3, 2014

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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