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Clinical Trials/NCT00223054
NCT00223054
Completed
Not Applicable

Polymorphism of the Cytochrome P450-system and the MDR-system in Renal Transplants Receiving the Immunosuppressive Drugs Tacrolimus, Sirolimus, Everolimus or Cyclosporine A

University Hospital Schleswig-Holstein1 site in 1 country200 target enrollmentMarch 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Function of Renal Transplant
Sponsor
University Hospital Schleswig-Holstein
Enrollment
200
Locations
1
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Detailed Description

Primary endpoint is the 1. serum creatinine in patients with and without polymorphysms 2. rate of rejections in patients with and without polymorphysms

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
October 2006
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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