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...
Date First Received: September 14, 2005
Last Updated: June 3, 2008
Verified by: University of Schleswig-Holstein, June 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2005
Overall Status: Recruiting
Estimated Enrollment: 200
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”
Condition Keyword(s):
Intervention(s):
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: Other, Retrospective
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: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Schleswig-Holstein
Overall Clinical Trial Officials and Contacts
Lutz Renders, MD Principal Investigator University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Overall Contact: Lutz Renders 00494315971338 renders@nephro.uni-kiel.de
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
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
Clinical Trials Authorship and Review
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