Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00264355
Status:
COMPLETED
Last Update Posted:
2007-09-06
First Post:
2005-12-09
Brief Title:
Metabolic Pattern of Cyclosporine A and Acute Renal Failure
Sponsor:
University of Oslo School of Pharmacy
Organization:
University of Oslo School of Pharmacy
Study Overview
Official Title:
Metabolic Pattern of Cyclosporine A - Association of Secondary- and Cyclic Metabolites With Acute Renal Failure in Heart Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None