Acute Renal Failure Clinical Trial
Official title:
Metabolic Pattern of Cyclosporine A - Association of Secondary- and Cyclic Metabolites With Acute Renal Failure in Heart Transplant Recipients
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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