Model based tacrolimus dosing

Objective: The key objective is to minimize the occurrence of subtherapeutic and supra-therapeutic C0 of tacrolimus in the immediate post-transplant phase by basing the starting dose on the dosing algorithm.

Study design: Prospective, single-arm, therapeutic intervention study
Study population: Adult kidney transplant recipients.

Intervention: All participants will receive the tacrolimus starting dose based on a dosing algorithm which takes genetic, demographic and clinical factors into account, rather than the standard bodyweight-based dose.

Main study parameters/endpoints: The main study parameter is the percentage of patients within the target C0 range of tacrolimus (7.5 to 12.5 ng/mL) on day 3 after kidney transplantation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extra burden is limited to one 7 mL EDTA blood sample and one 10 mL heparin blood sample for determining the intracellular tacrolimus concentration. These samples will be drawn at the same time as the regular tacrolimus blood sampling and therefore no extra vena puncture is necessary. All patients will receive identical care to those not included in the study. TDM will be performed and the tacrolimus dosage will be adjusted accordingly.

The key objective is to minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on days 3, 5, 7 and 10 after transplantation by basing the starting dose of tacrolimus on a dosing algorithm, rather than the standard bodyweight-only-based approach.

Day 3, 5, 7, 10 and 30 following transplantation

Tacrolimus starting dose based on a dosing algorithm