NCT00620841

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
Last Updated

February 22, 2008

Status Verified

January 1, 2008

Enrollment Period

8 months

First QC Date

February 13, 2008

Last Update Submit

February 21, 2008

Conditions

Renal Transplantation

Keywords

TacrolimusRenal Transplantationgenetic polymorphismsDrug drug interactions

Outcome Measures

Primary Outcomes (1)

  • Tacrolimus exposure parameters

    weeks

Secondary Outcomes (1)

  • Tacrolimus daily dosing

    weeks

Study Arms (1)

A

Patients treated with tacrolimus and experiencing a drug interaction

Other: genotyping

Interventions

genotypingOTHER

Restriction fragment lenght polymorphisms

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal transplant recipients treated with a calcineurin-inhibitor

You may qualify if:

  • Treatment with calcineurin-inhibitor
  • Renal transplantation

You may not qualify if:

  • Drug, alcohol addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Brabant, B-3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples

MeSH Terms

Interventions

Genotype

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Dirk R Kuypers, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 22, 2008

Study Start

May 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 22, 2008

Record last verified: 2008-01

Locations

BE(1)