Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients - Full Text View

Sponsored by:	Katholieke Universiteit Leuven
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00411944

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 IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
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.

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:

Kuypers DR, Claes K, Evenepoel P, Maes B, Coosemans W, Pirenne J, Vanrenterghem Y. Time-related clinical determinants of long-term tacrolimus pharmacokinetics in combination therapy with mycophenolic acid and corticosteroids: a prospective study in one hundred de novo renal transplant recipients. Clin Pharmacokinet. 2004;43(11):741-62.

Kuypers DR, Claes K, Evenepoel P, Maes B, Vanrenterghem Y. Clinical efficacy and toxicity profile of tacrolimus and mycophenolic acid in relation to combined long-term pharmacokinetics in de novo renal allograft recipients. Clin Pharmacol Ther. 2004 May;75(5):434-47.

Study ID Numbers:	TacLTPK
Study First Received:	December 13, 2006
Last Updated:	December 13, 2006
ClinicalTrials.gov Identifier:	NCT00411944 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Katholieke Universiteit Leuven:

tacrolimus pharmacokinetics
CYP3A4 - CYP3A5
P-glycoprotein

single nucleotide polymorphisms
renal transplantation
calcineurin-inhibitor-associated nephrotoxicity

Study placed in the following topic categories:

Immunologic Factors
Tacrolimus
Immunosuppressive Agents
PS-K

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Tacrolimus
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009