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Completed

NCT Number: NCT03512431

Dose Adjustment of Tacrolimus Based on Home Sampling in Renal Transplant Recipients

Repeated 12-hour pharmacokinetic (PK) investigations in renal transplant recipients for parallel sampling of standard venous bloods samples and finger prick micro samples (Mitra tips). Primary aim to validate the micro sampling tacrolimus concentrations against venous blood concentrations.

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Key information

Conditions

Renal Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital - Rikshospitalet

Oslo, 0424, Norway

About this study

Renal transplant recipients using Prograf® as part of their immunosuppressive regimen will be included in the study. Patients will receive oral and written study information and sign the informed consent before entering the study. A 12-hour pharmacokinetic investigation will be performed when Tac doses have been stable for at least 7 days (approximately 3-4 weeks posttransplant). They will continue on unchanged doses of tacrolimus as before PK investigation 1 (PK1). After at least another 7 days a second 12h PK-investigation (PK2) will be performed. If Tac doses needs to be changed after PK1 and before PK2 the second PK will not be performed.

Tac doses and blood concentration obtained as part of standard follow-up of the patients will be included in a non-parametric population model to obtain individually optimal sampling times for each patient using the MMopt function in Pmetrics®. During both PK1 and PK2 the patients themselves will be instructed to take two "home sampling" micro samples (Mitra® microsampling device) just prior to the standard vacutainer samples are obtained. Both the micro- and vacutainer samples will be drawn in 2 parallel samples right after each other and one will be mailed to the laboratory via standard mail. During PK1 the sampling times will be the same and standardized for all patients; before (0h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours after dose administration. During PK2 individually optimized sampling times based on 2, 3 and 4 samples will be determined using the MMopt function in Pmetrics and utilizing all individual dose and concentration information from before PK2, including the rich sampling during PK1. Spread over the entire study period, at least 6 real life home samplings for trough (C0) of Tac will also be performed by the patient and mailed to the hospital.

Tacrolimus induced tremor will be measured with a center-developed method utilizing infrared determined positioning (sampling ever 5 ms) of hand joints in the x-, y, z axis.

Who can participate

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

Inclusion criteria

  • Renal transplant recipients
  • Females and males
  • Patients receiving tacrolimus as part of their immunosuppressive therapy (clinical decision not influenced by this study)

Exclusion criteria

  • Patients on concomitant drugs with known pharmacokinetic interaction with tacrolimus

Treatment and study plan

Micro sampling

Diagnostic Test

Compare finger prick micro samples with venous blood samples for measuring whole blood tacrolimus concentrations

Primary outcomes

  1. Absolute bias of micro sample tacrolimus concentrations

    Time frame: Within one dose interval of 12 hours

    absolute bias (mico- minus vacutainer sampling) over the clinical range (1 to 40 µg/L) of micro sampled, including simulated "home sampled", Tac trough concentrations

  2. Relative bias of micro sample tacrolimus concentrations

    Time frame: Within one dose interval of 12 hours

    Relative bias (mico- minus vacutainer sampling divided by vacutainer sampled) over the clinical range (1 to 40 µg/L) of micro sampled, including simulated "home sampled", Tac trough concentrations

Secondary outcomes

  1. popPK Bayesian predicted tacrolimus trough concentration

    Time frame: Within one dose interval of 12 hours

    Absolute and relative predictive error of population pharmacokinetic Bayesian estimated Tac trough concentration based on LSS with 2, 3 and 4 individually optimal sampling times more than 2 hours from trough

  2. PK Bayesian predicted tacrolimus AUC0-12

    Time frame: Within one dose interval of 12 hours

    Absolute and relative predictive error of population pharmacokinetic Bayesian estimated Tac AUC0-12 based on LSS with 2, 3 and 4 individually optimal sampling times

  3. Tacrolimus tremor PK/PD relation

    Time frame: Within one dose interval of 12 hours

    Description of the mathematical relation between measured tacrolimus blood concentrations and specific Tac tremor over a dose interval

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Sandoz
  • The Norwegian association for renal disease and transplants

Registry information

Acronym: TacDrop

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 30, 2018
Registry last updated
Aug 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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