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Gene Polymorphisms in Tacrolimus Drug Interactions (DDI-TAC)

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ClinicalTrials.gov Identifier: NCT00620841
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 22, 2008
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
KU Leuven

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

Condition or disease Intervention/treatment
Renal Transplantation Other: genotyping

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Gene Polymorphisms in Tacrolimus Drug Interactions in Renal Transplant Patients
Study Start Date : May 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Group/Cohort Intervention/treatment
A
Patients treated with tacrolimus and experiencing a drug interaction
Other: genotyping
Restriction fragment lenght polymorphisms




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

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

Biospecimen Retention:   Samples With DNA
DNA samples


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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
KU Leuven
Fund for Scientific Research, Flanders, Belgium
Investigators
Principal Investigator: Dirk R Kuypers, MD, PhD Universitaire Ziekenhuizen Leuven

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

Keywords provided by KU 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