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| Name | Class |
|---|---|
| Rikshospitalet University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer dosed | Experimental | Patients for which the computer model will calculate the individual doses |
|
| Control | Active Comparator | Patients which will get their tacrolimus doses determined by experience transplant physicians |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer dosing | Other | Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Åsberg, PhD | OUS-Rikshospitalet and University of Oslo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olso university hospital - Rikshospitalet | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25886918 | Derived | Storset E, Asberg A, Skauby M, Neely M, Bergan S, Bremer S, Midtvedt K. Improved Tacrolimus Target Concentration Achievement Using Computerized Dosing in Renal Transplant Recipients--A Prospective, Randomized Study. Transplantation. 2015 Oct;99(10):2158-66. doi: 10.1097/TP.0000000000000708. |
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| Standard dose determination | Other | Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic |
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