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Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

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: NCT00411944
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : December 15, 2006
Information provided by:
KU Leuven

Brief Summary:
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 or disease
Renal Transplantation

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.

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Study Type : Observational
Enrollment : 100 participants
Observational Model: Defined Population
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.
Study Start Date : August 1999
Study Completion Date : September 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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): NCT00411944

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Department of Nephology and Renal Transplantation
Leuven, Belgium, B-3000
Sponsors and Collaborators
KU Leuven
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Principal Investigator: Dirk R Kuypers, MD, PhD Dpt Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium
Publications of Results:
Layout table for additonal information Identifier: NCT00411944    
Other Study ID Numbers: TacLTPK
First Posted: December 15, 2006    Key Record Dates
Last Update Posted: December 15, 2006
Last Verified: December 2006
Keywords provided by KU Leuven:
tacrolimus pharmacokinetics
single nucleotide polymorphisms
renal transplantation
calcineurin-inhibitor-associated nephrotoxicity