Computer Guided Doing of Tacrolimus in Renal Transplantation

Renal Transplantation Clinical Trial

— OPTIMAL  

Official title:

Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010320
• Other study ID #: OPTIMAL-13
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2013
• Last updated: December 2, 2014
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: University of Oslo School of Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• renal transplant recipients using tacrolimus as part of their immunosuppression

• above 18 years

• signed informed consent

Exclusion Criteria:

• no specific

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

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

Locations

Country	Name	City	State
Norway	Olso university hospital - Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy	Rikshospitalet University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Influence of CYP3A5 genotyping	The model will be run without any information about patients CYP3A5 genotype as this is not clinical praxis at our center yet. All patients will however be genotyped after the study and a model including this covariate will be used to recalculate the data and see if this model is superior to the simple model, primary by comparing predictive errors in the computer arm.	8 to 12 weeks post-transplant	No
Primary	Predictive error (Cpred-Cobs)	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.	8 to 12 weeks	No
Primary	Reaching the target concentration	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.	8 to 12 weeks post-transplant	No