Computer Guided Doing of Tacrolimus in Renal Transplantation

Phase 4

Completed

• Conditions: Renal Transplantation
• Interventions: Other: Computer dosing; Other: Standard dose determination

• Registration Number: NCT02010320
• Lead Sponsor: University of Oslo School of Pharmacy

Brief 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.

Study Timeline

• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-12
• Study Start: 2014-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• no specific

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer dosed	Computer dosing	Patients for which the computer model will calculate the individual doses
Control	Standard dose determination	Patients which will get their tacrolimus doses determined by experience transplant physicians

Primary Outcome Measures

Name	Time	Method
Reaching the target concentration	8 to 12 weeks post-transplant	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.
Predictive error (Cpred-Cobs)	8 to 12 weeks	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.

Trial Locations

Locations (1)

Olso university hospital - Rikshospitalet; 🇳🇴 Oslo, Norway