Renal Function and Pharmacogenetics in Renal Transplant Recipients Converted From Tac BID to Tac OD
A Retrospective Analysis of Renal Function, Tac Dose Adjustments and CYP3A5 Pharmacogenetics in Stable Renal Transplant Recipients Converted From Tac BID to Tac OD
In Kidney transplant recipients Once daily Tacrolimus has the poteb]ntial advantage of better adnerence, and perhpas improvement in reanl function compred with the twice daily tacrolimus formulation.
Our center has the largest experience in North America with once-daily tacrolimus ( advagraf) in Renal transplant recipients.
Recently we converted ~500 stable patients from the twice daily to once-daily tacrolimus.
We are interested in:
- change in renal function
- dose changes based on ethnic diveristy
- dose changes based on pharmacogenetics
This will helpnus understand better ways to utilize this anti-rejection medication
Studieoversigt
Status
Detaljeret beskrivelse
The Renal transplant program at St. Michael's is one of the largest in Canada. The CNI of choice since 2000 has been tacrolimus based therapy. In 2009 our program decided to switch from bid prograf to once daily advagraf for all de-novo renal transplant recipients (RTR). Our Advagraf experience is currently the largest in North America. Because of concerns regarding generic prograf, we began a conversion of > 600 prevalent transplant patients on bid prograf to OD advagraf in January 2012. At present this is nearly completed.
It has been recognized that dosing of tacrolimus is highly dependent on pharmacogenentic differences related to the CYP3A5 genotype. CYP3A%*3 (nonexpressors) require significantly higher doses of tacrolimus than CYP3A5*1 (expressers) with heterozygotes being somewhere in the middle. Our study will examine the demographics, renal function and tacrolimus dosing and Co levels, both pre and post conversion from tac BID, to tac OD in our cohort of converted patients.
Of More scientific interest, will be to retrospectively determine the CYP3A5 genotypes in recipients who required significant dose adjustments in the tac OD following conversion and compare to a matched cohort of recipients in whom no dose adjustment was needed.
The hypothesis is that recipients who require dose increase when converted from the BID to the OD formulation, will have a different CYP3A5 genotype and will tend towards CYP3A5*3.
This will be the largest cohort to look at this question. Specifically this may lead to better dosing of tac OD, if pre-emptive genotyping prior to transplantation were to be employed.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5B1W8
- St.Michael's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria: Renal transplamnt recipients on prograf converted to advagraf
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Exclusion Criteria:
- none
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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500 Stable renal transplant recipients
cohort of 500 stable RTRS.
A subset of this group who required dose adjustment after conversion will be compared to a matched cohort not requiring dose adjustment.
Genotyping for Cyp3A5 will be done for both cohorts
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500 renal transplant recipients
500 Stable renal transplant recipients converted from prograf to advagraf
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Difference in Cyp3a5 genotype in recipients requiring dose adjustment in converion from prograf to advagraf
Tidsramme: 12 months
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12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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change in renal function after conversion from prograf to advagraf
Tidsramme: 6 months
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
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
- FK17
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