Polymorphism of the Cytochrome P450-system in Renal Transplants

Completed

• Conditions: Function of Renal Transplant

• Registration Number: NCT00223054
• Lead Sponsor: University Hospital Schleswig-Holstein

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

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2006-06
• Study Completion: 2006-10
• Status Verified: 2008-06
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Schleswig-Holstein, Campus Kiel, Department of Nephrology; 🇩🇪 Kiel, Germany