Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03830255
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2019-02-01
Brief Title:
Effect of Genetic Polymorphism on Calcineurin Inhibitors Levels in Egyptian Renal Transplant Patients
Sponsor:
Helwan University
Organization:
Helwan University
Study Overview
Official Title:
Calcineurin Inhibitors Among Egyptian Renal Transplant Patients a Pharmacognetic Based Study
Status:
COMPLETED
Status Verified Date:
2021-03
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:
Renal transplantation is the treatment of choice for patients with end-stage renal disease ESRD Calcineurin Inhibitors tacrolimus and cyclosporine are the principle immunosuppressive agents administered to solid organ transplant recipients to prevent and treat allograft rejection
The aim of the present study is to detect the incidence of some selected genetic polymorphism in Egyptian renal transplant population and investigate the influence of these genetic polymorphism SNPs on Cyclosporine and Tacrolimus blood concentration In addition to detect the association between these genetic polymorphism variants and patients clinical outcome after transplantation
The aim of the present study is to detect the incidence of some selected genetic polymorphism in Egyptian renal transplant population and investigate the influence of these genetic polymorphism SNPs on Cyclosporine and Tacrolimus blood concentration In addition to detect the association between these genetic polymorphism variants and patients clinical outcome after transplantation
Detailed Description:
Tacrolimus and cyclosporine are the principle immunosuppressive agents administered to solid organ transplant recipients to prevent and treat allograft rejectionThey both exert their immunosppressive action by inhibiting the calcinurein in T-lymphoctes SubsequentlyCyclosporin and tacrolimus are both metabolic substrates for cytochrome P450 CYP 3A enzymes - in particular CYP3A4 and CYP3A5 - and are transported out of cells by the P-glycoprotein ABCB1 efflux pump Different expression of CYP3A4 CYP3A5 and P-glycoprotein causes patient to-patient variability in the absorption metabolism and tissue distribution of calcineurin inhibitors This different expression is likely to be at least partially the result of mutations in the genes encoding for these enzymes and drug transporter This may lead to variable drug concentrations within the systemic circulation and at target sites influencing drug efficacy Moreover it will influence the individuals susceptibility to drug interactions and drug toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None