Metabolic Pattern of Cyclosporine A and Acute Renal Failure
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
Following heart transplantation many patients develop acute renal failure in the early
posttransplant phase and some are in need of renal replacement therapy for shorter or longer
time. The cause of this acute renal failure is most probably multi factorial but many reports
indicate that cyclosporine has a central role in the pathophysiology and it is generally
recommended to lower the cyclosporine load to patients developing acute renal failure in this
population.
Several in vitro studies on renal cells in culture indicate that the primary metabolites of
cyclosporine (AM1, AM9, AM4N) are less toxic to the kidney than cyclosporine itself. However,
the secondary metabolite AM19 as well as the cyclic metabolites AM1c and AM1c9 has been
associated with decreased renal function and nephrotoxicity renal transplant recipients.
The primary objective of this pilot study is to investigate if the concentrations of
secondary- and cyclic metabolites of cyclosporine (AM19, AM1c, AM1c9) is related to
development of acute renal failure in the early posttransplant phase following heart
transplantation.
Secondary objectives are to investigate associations between genotypes of P-glycoprotein and
CYP3A5 and the metabolic pattern of cyclosporine.