Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Polymorphism of the Cytochrome P450-system in Renal Transplants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223054
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 4, 2011
Sponsor:
Collaborator:
University of Kiel
Information provided by:
University Hospital Schleswig-Holstein

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.


Condition or disease Intervention/treatment
Function of Renal Transplant Drug: tacrolimus Drug: sirolimus Drug: everolimus Drug: cyclosporin A

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Time Perspective: Retrospective
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
Study Start Date : March 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Biospecimen Retention:   Samples With DNA
DNA samples to analyze polymorphisms


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patinets after kidney transplantation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223054


Locations
Layout table for location information
Germany
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Kiel, Germany, 24105
Sponsors and Collaborators
University Hospital Schleswig-Holstein
University of Kiel
Investigators
Layout table for investigator information
Principal Investigator: Lutz Renders, MD University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Publications of Results:
Layout table for additonal information
Responsible Party: Lutz Renders, University of Kiel
ClinicalTrials.gov Identifier: NCT00223054    
Other Study ID Numbers: 004
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: June 2008
Keywords provided by University Hospital Schleswig-Holstein:
cyclosporin A
Tacrolimus
Everolimus
Sirolimus
Fluvastatin
Additional relevant MeSH terms:
Layout table for MeSH terms
Cyclosporine
Sirolimus
Everolimus
Tacrolimus
Cyclosporins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic