This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

This study has been completed.
Information provided by:
Katholieke Universiteit Leuven Identifier:
First received: December 13, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
An evaluation of the effects of genetically determined variant metabolizing and transporting proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal transplant recipients. In a five year follow-up study tacrolimus dose-corrected exposure changes significantly and the effect(s) of single nucleotide polymorphisms of the CYP3A4/CYP3A5 and MDR1 genes on the latter is assessed in this study.

Condition Phase
Renal Transplantation Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Prospective Study of the Influence of CYP3A4/CYP3A5 and MDR1 Gene Single Nucleotide Polymorphisms on Long-Term Tacrolimus Disposition in Renal Allograft Recipients: a Five Year Follow-up Study Using Abbreviated Concentration-Time Measurements.

Resource links provided by NLM:

Further study details as provided by Katholieke Universiteit Leuven:

Estimated Enrollment: 100
Study Start Date: August 1999
Estimated Study Completion Date: September 2005
Detailed Description:
A 5-year pharmacokinetic follow-up study in 95 renal allograft recipients assessing tacrolimus exposure using repeated abbreviated Area-Under-the-Concentration-time (AUC) curve measurements at regular time points after grafting. The effects of the CYP3A5*1, CYP3A4*1B, MDR1 G2677T/A and C3435T single nucleotide polymorphisms on the evolution of tacrolimus disposition are studied over 5 years in order to clarify the interrelationship between CYP3A5, CYP3A4 and MDR1 genotypes, time-dependent exposure and tacrolimus-related toxicity.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary or secondary single kidney transplantation
  • Age older than 18 yrs

Exclusion Criteria:

  • Combined organ transplantation
  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 identifier: NCT00411944

Department of Nephology and Renal Transplantation
Leuven, Belgium, B-3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Principal Investigator: Dirk R Kuypers, MD, PhD Dpt Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium
  More Information

Publications: Identifier: NCT00411944     History of Changes
Other Study ID Numbers: TacLTPK
Study First Received: December 13, 2006
Last Updated: December 13, 2006

Keywords provided by Katholieke Universiteit Leuven:
tacrolimus pharmacokinetics
single nucleotide polymorphisms
renal transplantation
calcineurin-inhibitor-associated nephrotoxicity

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017