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CompletedNCT00411944Updated Dec 15, 2006

Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

An observational study in Renal Transplantation, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-12-15.

Sponsored by KU Leuven · Observational

Study type
Observational
Model
Defined population
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Transplantation

Keywords

  • tacrolimus pharmacokinetics
  • CYP3A4 - CYP3A5
  • P-glycoprotein
  • single nucleotide polymorphisms
  • renal transplantation
  • calcineurin-inhibitor-associated nephrotoxicity
03

In context

Lead sponsor

KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Combined organ transplantation
05

Study design

Observational model
Defined population
Time perspective
Prospective
Enrollment
100 participants
06

Study locations

1 site
  • Department of Nephology and Renal Transplantation
    Leuven, B-3000, Belgium
07

References and documents

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. doi: 10.2165/00003088-200443110-00005. PubMed 15301578 ↗
  • 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. PubMed 15116056 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00411944
Lead sponsor
KU Leuven
First posted
Dec 15, 2006
Start date
Aug 1999
Completion
Sep 2005
Last update
Dec 15, 2006

Study contacts

Dirk R Kuypers, MD, PhD
principal investigator · Dpt Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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