Polymorphism of the Cytochrome P450-system in Renal Transplants

Function of Renal Transplant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223054
• Other study ID #: 004
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: August 3, 2011
• Start date: March 2005
• Est. completion date: October 2006

Study information

• Verified date: June 2008
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Description:

Primary endpoint is the

1. serum creatinine in patients with and without polymorphysms

2. rate of rejections in patients with and without polymorphysms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Function of Renal Transplant

Intervention

Drug:
• tacrolimus
retrospective analyze of drug levels in comparison to polymorphism
• sirolimus
retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
• everolimus
retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
• cyclosporin A
retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism

Locations

Country	Name	City	State
Germany	University of Schleswig-Holstein, Campus Kiel, Department of Nephrology	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	University of Kiel

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation