Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-08-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Transplantation

Keywords

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tacrolimus pharmacokinetics CYP3A4 - CYP3A5 P-glycoprotein single nucleotide polymorphisms renal transplantation calcineurin-inhibitor-associated nephrotoxicity

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Combined organ transplantation

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Dirk R Kuypers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dpt Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium

Locations

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Department of Nephology and Renal Transplantation

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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. doi: 10.2165/00003088-200443110-00005.

Reference Type RESULT

PMID: 15301578 (View on PubMed)

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. doi: 10.1016/j.clpt.2003.12.009.