NCT00411944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
Last Updated

December 15, 2006

Status Verified

December 1, 2006

First QC Date

December 13, 2006

Last Update Submit

December 13, 2006

Conditions

Renal Transplantation

Keywords

tacrolimus pharmacokineticsCYP3A4 - CYP3A5P-glycoproteinsingle nucleotide polymorphismsrenal transplantationcalcineurin-inhibitor-associated nephrotoxicity

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Combined organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephology and Renal Transplantation

Leuven, B-3000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 15301578RESULT

  • 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.

    PMID: 15116056RESULT

Study Officials

  • Dirk R Kuypers, MD, PhD

    Dpt Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2006

First Posted

December 15, 2006

Study Start

August 1, 1999

Study Completion

September 1, 2005

Last Updated

December 15, 2006

Record last verified: 2006-12

Locations

BE(1)