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Gene Polymorphisms in Tacrolimus Drug Interactions (DDI-TAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620841
First Posted: February 22, 2008
Last Update Posted: February 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
Katholieke Universiteit Leuven
  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:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Tacrolimus exposure parameters [ Time Frame: weeks ]

Secondary Outcome Measures:
  • Tacrolimus daily dosing [ Time Frame: weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Catholic University Leuven, University Hospitals, University Hospital Gasthuisberg
ClinicalTrials.gov Identifier: NCT00620841     History of Changes
Other Study ID Numbers: DDI-001
First Submitted: February 13, 2008
First Posted: February 22, 2008
Last Update Posted: February 22, 2008
Last Verified: January 2008

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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action