Computer Guided Doing of Tacrolimus in Renal Transplantation

Phase 4CompletedNCT02010320

University of Oslo School of Pharmacy80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

Computer dosingOTHER

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

Standard dose determinationOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * renal transplant recipients using tacrolimus as part of their immunosuppression * above 18 years * signed informed consent Exclusion Criteria: * no specific

Locations (1)

Olso university hospital - Rikshospitalet

Oslo, Norway

Outcomes

Primary Outcomes

Predictive error (Cpred-Cobs)

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.

Time frame: 8 to 12 weeks

Reaching the target concentration

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.

Time frame: 8 to 12 weeks post-transplant

Data from ClinicalTrials.gov

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