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Renal Function and Pharmacogenetics in Renal Transplant Recipients Converted From Tac BID to Tac OD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01884480
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:

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:

  1. change in renal function
  2. dose changes based on ethnic diveristy
  3. dose changes based on pharmacogenetics

This will helpnus understand better ways to utilize this anti-rejection medication

Condition or disease
Real Function Post Conversion From Prograf to Advagraf Examin Ethnicity and Pharmacogenetics of the Cohort Requiring Dose Adjustment Post-conversion

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Renal Function, Tac Dose Adjustments and CYP3A5 Pharmacogenetics in Stable Renal Transplant Recipients Converted From Tac BID to Tac OD
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

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
500 renal transplant recipients
500 Stable renal transplant recipients converted from prograf to advagraf

Primary Outcome Measures :
  1. Difference in Cyp3a5 genotype in recipients requiring dose adjustment in converion from prograf to advagraf [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. change in renal function after conversion from prograf to advagraf [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
500 stable renal transplant recipients

Inclusion Criteria: Renal transplamnt recipients on prograf converted to advagraf


Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01884480

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Canada, Ontario
St.Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT01884480    
Other Study ID Numbers: FK17
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by St. Michael's Hospital, Toronto:
Advagraf, pharmacogenetics, Cyp3A5