Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433953
Status:
TERMINATED
Last Update Posted:
2013-02-20
First Post:
2007-02-08
Brief Title:
Genetic Drug Study of Mycophenolic Acid CellCept in Pediatric Kidney Transplant Patients
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Pharmacogenetics of Mycophenolic Acid in Kidney Transplant Patients
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No longer following patient and no plans to publish
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine how genes influence the response to mycophenolate mofetil CellCept in children who have had a kidney transplant The study will look at how differences in some genes effect blood levels of mycophenolate mofetil over time in children how often side effects occur and the way that children respond to mycophenolate mofetil
The results may lead to better dosing based on individual needs
The results may lead to better dosing based on individual needs
Detailed Description:
This is an open label inpatient-outpatient prospective observational study to determine whether the inter-patient variability in mycophenolic acid MPA pharmacokinetics and exposure adverse events and clinical response in pediatric transplant patients ages 2-18 years is associated with identifiable pharmacogenetic factors Specific aims 1 To determine whether common polymorphic variations in the uridine diphosphate-glucuronosyltransferases UGTs are associated with inter-individual variability in MPA pharmacokinetics and exposure by affecting MPA metabolism 2 To determine whether common polymorphic variations in the uridine diphosphate-glucuronosyltransferases UGTs are associated with inter-patient differences in the incidence of adverse events by affecting the formation of the acyl-glucuronide metabolite Enrolled subjects will have been receiving mycophenolate mofetil as part of their clinical standard of care It is anticipated that the clinical portion of the study will last up to 4 hours at one study visit to include one pharmacogenetic blood sample and 4 pharmacokinetic blood samples collected out to 3 hours post-dose Safety data to be collected will include standard of care physical exam and safety laboratory tests as well as data on adverse events and clinical outcomes
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