Computer Guided Doing of Tacrolimus in Renal Transplantation (OPTIMAL)

University of Oslo School of Pharmacy

Status and phase: Completed; Phase 4

Conditions: Renal Transplantation

Treatments: Other: Standard dose determination; Other: Computer dosing

Study type: Interventional

Funder types: Other

Identifiers

NCT02010320

OPTIMAL-13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• no specific

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Computer dosed

Experimental group

Description:

Patients for which the computer model will calculate the individual doses

Treatment:

Other: Computer dosing

Control

Active Comparator group

Description:

Patients which will get their tacrolimus doses determined by experience transplant physicians

Treatment:

Other: Standard dose determination