Gene Polymorphisms in Tacrolimus Drug Interactions | NCT00620841

Studies
Gene Polymorphisms in Tacrolimus Drug Interactions

NCT00620841

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Feb 22, 2008Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Renal Transplantation

Interventions

genotyping

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Feb 13, 2008

First Submission Date that Met QC Criteria

Feb 21, 2008

First Posted Date

Feb 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2008

Last Update Posted Date

Feb 22, 2008Estimated

Name	Class
Fund for Scientific Research, Flanders, Belgium	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Patients treated with tacrolimus and experiencing a drug interaction	Other: genotyping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
genotyping	Other	Restriction fragment lenght polymorphisms	A

Measure	Description	Time Frame
Tacrolimus exposure parameters		weeks

Measure	Description	Time Frame
Tacrolimus daily dosing		weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment with calcineurin-inhibitor
Renal transplantation

Exclusion Criteria:

Drug, alcohol addiction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Renal transplant recipients treated with a calcineurin-inhibitor

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dirk R Kuypers, MD, PhD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leuven		Leuven	Brabant	B-3000	Belgium