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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Oslo, Norge, 0424
- Olso university hospital - Rikshospitalet
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- renal transplant recipients using tacrolimus as part of their immunosuppression
- above 18 years
- signed informed consent
Exclusion Criteria:
- no specific
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Computer dosed
Patients for which the computer model will calculate the individual doses
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Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates
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Aktiv komparator: Control
Patients which will get their tacrolimus doses determined by experience transplant physicians
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Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Predictive error (Cpred-Cobs)
Tidsramme: 8 to 12 weeks
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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.
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8 to 12 weeks
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Reaching the target concentration
Tidsramme: 8 to 12 weeks post-transplant
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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.
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8 to 12 weeks post-transplant
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Influence of CYP3A5 genotyping
Tidsramme: 8 to 12 weeks post-transplant
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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.
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8 to 12 weeks post-transplant
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Anders Åsberg, PhD, OUS-Rikshospitalet and University of Oslo
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- OPTIMAL-13
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