NCT00411944

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (planned)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Timeline

• Start date: 1999-08-01
• Completion: 2005-09-01
• First posted: 2006-12-15
• Last updated: 2006-12-15

Locations

1 site across 1 country: Belgium