NCT00223054

Polymorphism of the Cytochrome P450-system in Renal Transplants

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Function of Renal Transplant

Interventions

Type	Name	Description
DRUG	tacrolimus	retrospective analyze of drug levels in comparison to polymorphism
DRUG	sirolimus	retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
DRUG	everolimus	retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
DRUG	cyclosporin A	retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-06-01
• Completion: 2006-10-01
• First posted: 2005-09-22
• Last updated: 2011-08-04

Locations

1 site across 1 country: Germany