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Gene Polymorphisms in Tacrolimus Drug Interactions (DDI-TAC)

This study has been completed.
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00620841
First received: February 13, 2008
Last updated: February 21, 2008
Last verified: January 2008
History of Changes
  Purpose

A retrospective analysis of the influence of gene polymorphisms on drug interactions between calcineurin-inhibitors and concomitant drugs in renal transplant patients.


Condition Intervention
Renal Transplantation
 Other: genotyping

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Gene Polymorphisms in Tacrolimus Drug Interactions in Renal Transplant Patients

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Tacrolimus exposure parameters [ Time Frame: weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tacrolimus daily dosing [ Time Frame: weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA samples


Enrollment: 40
Study Start Date: May 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Patients treated with tacrolimus and experiencing a drug interaction
 Other: genotyping
Restriction fragment lenght polymorphisms

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Renal transplant recipients treated with a calcineurin-inhibitor

Criteria

Inclusion Criteria:

  • Treatment with calcineurin-inhibitor
  • Renal transplantation

Exclusion Criteria:

  • Drug, alcohol addiction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620841

Locations
Belgium
University Hospitals Leuven
Leuven, Brabant, Belgium, B-3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Fund for Scientific Research, Flanders, Belgium
Investigators
Principal Investigator: Dirk R Kuypers, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Catholic University Leuven, University Hospitals, University Hospital Gasthuisberg
ClinicalTrials.gov Identifier: NCT00620841     History of Changes
Other Study ID Numbers: DDI-001
Study First Received: February 13, 2008
Last Updated: February 21, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:
Tacrolimus
Renal Transplantation
genetic polymorphisms
Drug drug interactions

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013