NCT02010320

Computer Guided Doing of Tacrolimus in Renal Transplantation

Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Oslo School of Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
OTHER	Computer dosing	Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates
OTHER	Standard dose determination	Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-12-12
• Last updated: 2014-12-03

Locations

1 site across 1 country: Norway