Trial record 13 of 763 for:    pharmacogenomics OR pharmacogenetics

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
Jeffrey Zaltzman, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01884480
First received: June 19, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Difference in Cyp3a5 genotype in recipients requiring dose adjustment in converion from prograf to advagraf [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change in renal function after conversion from prograf to advagraf [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

500 stable renal transplant recipients

Criteria

Inclusion Criteria: Renal transplamnt recipients on prograf converted to advagraf

-

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884480

Locations
Canada, Ontario
St.Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Jeff S zaltzman, MD, FRCP(C)    416-867-7444    zaltzmanj@smh.ca   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Jeffrey Zaltzman, Director of Transplant, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01884480     History of Changes
Other Study ID Numbers: FK17
Study First Received: June 19, 2013
Last Updated: February 18, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Advagraf, pharmacogenetics, Cyp3A5

ClinicalTrials.gov processed this record on July 29, 2014