Gene Polymorphisms in Tacrolimus Drug Interactions (DDI-TAC)

February 21, 2008 updated by: KU Leuven

Gene Polymorphisms in Tacrolimus Drug Interactions in Renal Transplant Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brabant
      • Leuven, Brabant, Belgium, B-3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal transplant recipients treated with a calcineurin-inhibitor

Description

Inclusion Criteria:

  • Treatment with calcineurin-inhibitor
  • Renal transplantation

Exclusion Criteria:

  • Drug, alcohol addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tacrolimus exposure parameters
Time Frame: weeks
weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Tacrolimus daily dosing
Time Frame: weeks
weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Fund for Scientific Research, Flanders, Belgium

Investigators

  • Principal Investigator: Dirk R Kuypers, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 22, 2008

Last Update Submitted That Met QC Criteria

February 21, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DDI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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