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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00223054
Enrollment
200
Registered
2005-09-22
Start date
2005-03-31
Completion date
2006-10-31
Last updated
2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Function of Renal Transplant

Keywords

cyclosporin A, Tacrolimus, Everolimus, Sirolimus, Fluvastatin

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

Interventions

DRUGtacrolimus

retrospective analyze of drug levels in comparison to polymorphism

DRUGsirolimus

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

DRUGeverolimus

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

DRUGcyclosporin A

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

Sponsors

University of Kiel
CollaboratorOTHER
University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026