Polymorphism of the Cytochrome P450-system in Renal Transplants
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...
Brief Summary
Official Title: “Polymorphism of the Cytochrome P450-system and the MDR-system in Renal Transplants Receiving the Immunosuppressive Drugs Tacrolimus, Sirolimus, Everolimus or Cyclosporine A”
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.
- Study Type: Observational
- Study Design: Time Perspective: Retrospective
- Study Primary Completion Date: June 2006
Detailed Clinical Trial Description
Primary endpoint is the
1. serum creatinine in patients with and without polymorphysms
2. rate of rejections in patients with and without polymorphysms
Intervention(s) in this Clinical Trial
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of Schleswig-Holstein Other
Overall Clinical Trial Officials and Contacts
Lutz Renders, MD Principal Investigator University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Related Publications
Citations Reporting Results
Renders L, Frisman M, Ufer M, Mosyagin I, Haenisch S, Ott U, Caliebe A, Dechant M, Braun F, Kunzendorf U, Cascorbi I. CYP3A5 genotype markedly influences the pharmacokinetics of tacrolimus and sirolimus in kidney transplant recipients. Clin Pharmacol Ther. 2007 Feb;81(2):228-34. Epub 2006 Dec 27.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00223054
Study ID Number: 004
ClinicalTrials.gov Identifier: NCT00223054
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00223054
