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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
-
Oslo, Norge, 0424
- Olso university hospital - Rikshospitalet
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Predictive error (Cpred-Cobs)
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Influence of CYP3A5 genotyping
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Anders Åsberg, PhD, OUS-Rikshospitalet and University of Oslo
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- OPTIMAL-13
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .