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NCT00620841 Clinical Trial

Gene Polymorphisms in Tacrolimus Drug Interactions

Renal Transplantation Clinical Trial

— DDI-TAC  

Official title:
Gene Polymorphisms in Tacrolimus Drug Interactions in Renal Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00620841
Other study ID # DDI-001
Secondary ID
Status Completed
Phase N/A
First received February 13, 2008
Last updated February 21, 2008
Start date May 2007
Est. completion date January 2008

Study information
Verified date January 2008
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Treatment with calcineurin-inhibitor

- Renal transplantation

Exclusion Criteria:

- Drug, alcohol addiction

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• genotyping
Restriction fragment lenght polymorphisms

Locations
Country Name City State
Belgium University Hospitals Leuven Leuven Brabant

Sponsors (2)
Lead Sponsor Collaborator
Katholieke Universiteit Leuven Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tacrolimus exposure parameters weeks No
Secondary Tacrolimus daily dosing weeks No
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