Renal Transplantation Clinical Trial
Official title:
Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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