Polymorphism of the Cytochrome P450-system in Renal Transplants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-10-31

Brief Summary

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In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A).

All patients who receive one of these drugs can be included and drug blood trough levels, dosing and genetics are compared.

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Detailed Description

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Primary endpoint is the

1. serum creatinine in patients with and without polymorphysms
2. rate of rejections in patients with and without polymorphysms

Conditions

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Function of Renal Transplant

Study Design

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Study Time Perspective

RETROSPECTIVE

Interventions

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tacrolimus

retrospective analyze of drug levels in comparison to polymorphism

Intervention Type DRUG

sirolimus

retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism

Intervention Type DRUG

everolimus

retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism

Intervention Type DRUG

cyclosporin A

retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Renal transplant patients receiving one or more of the following drugs:

* tacrolimus
* sirolimus
* everolimus
* cyclosporin A
* fluvastatin
* Informed consent given by the patient

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No