Gene Polymorphisms in Tacrolimus Drug Interactions - Full Text View

Gene Polymorphisms in Tacrolimus Drug Interactions (DDI-TAC)

This study has been completed.

First Received: February 13, 2008 Last Updated: February 21, 2008 History of Changes

Sponsors and Collaborators:	Katholieke Universiteit Leuven Fund for Scientific Research, Flanders, Belgium
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00620841

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

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

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

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

Biospecimen Description:

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, Brabant
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

University Hospitals Leuven Belgium

More Information

No publications provided

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

Keywords provided by Katholieke Universiteit Leuven:

Tacrolimus
Renal Transplantation
genetic polymorphisms
Drug drug interactions

Study placed in the following topic categories:

Immunologic Factors
Tacrolimus
Immunosuppressive Agents

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Tacrolimus
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009