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

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ClinicalTrials.gov Identifier: NCT01884480
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date June 19, 2013
First Posted Date June 24, 2013
Last Update Posted Date November 19, 2014
Study Start Date June 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2013)
Difference in Cyp3a5 genotype in recipients requiring dose adjustment in converion from prograf to advagraf [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 21, 2013)
change in renal function after conversion from prograf to advagraf [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Renal Function and Pharmacogenetics in Renal Transplant Recipients Converted From Tac BID to Tac OD
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
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

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 500 stable renal transplant recipients
Condition
  • Real Function Post Conversion From Prograf to Advagraf
  • Examin Ethnicity and Pharmacogenetics of the Cohort Requiring Dose Adjustment Post-conversion
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Zaltzman AS, Glick LA, Zaltzman JS, Nash M, Huang M, Prasad GV. The role of CYP3A5 polymorphism and dose adjustments following conversion of twice-daily to once-daily tacrolimus in renal transplant recipients. Transplant Res. 2016 Jan 28;5:2. doi: 10.1186/s13737-016-0031-6. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 18, 2014)
60
Original Estimated Enrollment
 (submitted: June 21, 2013)
500
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria: Renal transplamnt recipients on prograf converted to advagraf

-

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01884480
Other Study ID Numbers FK17
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor St. Michael's Hospital, Toronto
Collaborators Not Provided
Investigators Not Provided
PRS Account St. Michael's Hospital, Toronto
Verification Date November 2014