Computer Guided Doing of Tacrolimus in Renal Transplantation (OPTIMAL)
Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
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-
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Oslo, Norge, 0424
- Olso university hospital - Rikshospitalet
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- renal transplant recipients using tacrolimus as part of their immunosuppression
- above 18 years
- signed informed consent
Exclusion Criteria:
- no specific
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Computer dosed
Patients for which the computer model will calculate the individual doses
|
Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates
|
|
Aktiv komparator: Control
Patients which will get their tacrolimus doses determined by experience transplant physicians
|
Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Predictive error (Cpred-Cobs)
Tidsram: 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.
|
8 to 12 weeks
|
|
Reaching the target concentration
Tidsram: 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.
|
8 to 12 weeks post-transplant
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Influence of CYP3A5 genotyping
Tidsram: 8 to 12 weeks post-transplant
|
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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Anders Åsberg, PhD, OUS-Rikshospitalet and University of Oslo
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- OPTIMAL-13
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