Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00411944
• Lead Sponsor: KU Leuven

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.

Study Timeline

• Study Start: 1999-08
• Study Completion: 2005-09
• Status Verified: 2006-12
• Study First Submitted: 2006-12-13
• Study First Submitted QC: 2006-12-13
• Last Update Submitted: 2006-12-13
• Study First Posted: 2006-12-15
• Last Update Posted: 2006-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Combined organ transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Department of Nephology and Renal Transplantation; 🇧🇪 Leuven, Belgium