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Completed

NCT Number: NCT00223054

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 compared.

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Key information

Conditions

Function of Renal Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Schleswig-Holstein, Campus Kiel, Department of Nephrology

Kiel, 24105, Germany

About this study

Primary endpoint is the

  • serum creatinine in patients with and without polymorphysms
  • rate of rejections in patients with and without polymorphysms

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

retrospective analyze of drug levels in comparison to polymorphism

sirolimus

Drug

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

Everolimus

Drug

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

cyclosporin A

Drug

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

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • University of Kiel

Registry information

Official study title

Polymorphism of the Cytochrome P450-system and the MDR-system in Renal Transplants Receiving the Immunosuppressive Drugs Tacrolimus, Sirolimus, Everolimus or Cyclosporine A

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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