Polymorphism of the Cytochrome P450-system in Renal Transplants

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Function of Renal Transplant

Treatments: Drug: everolimus; Drug: sirolimus; Drug: cyclosporin A; Drug: tacrolimus

Study type: Observational

Funder types: Other

Identifiers

NCT00223054

004

Details and patient eligibility

About

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.

Full description

Primary endpoint is the

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

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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