Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00411944

Enrollment

100

Registered

2006-12-15

Start date

1999-08-31

Completion date

2005-09-30

Last updated

2006-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

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

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.

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.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Combined organ transplantation

Countries

Belgium

Outcome results