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Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

This study has been completed.
Sponsor:
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00411944
First received: December 13, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Combined organ transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411944

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

Publications:

ClinicalTrials.gov Identifier: NCT00411944     History of Changes
Other Study ID Numbers: TacLTPK
Study First Received: December 13, 2006
Last Updated: December 13, 2006
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Katholieke Universiteit Leuven:
tacrolimus pharmacokinetics
CYP3A4 - CYP3A5
P-glycoprotein
 single nucleotide polymorphisms
renal transplantation
calcineurin-inhibitor-associated nephrotoxicity

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013