Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281619
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2006-01-23
Brief Title:
PK-PD 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:
Development of Population Pharmacokinetic-Pharmacodynamic PK-PD Models of Mycophenolic Acid for Bayesian Dose Individualization in Pediatric Kidney Transplant Patients
Status:
COMPLETED
Status Verified Date:
2013-12
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:
The purpose of this study is to determine how fast children who have had a recent kidney transplant absorb breakdown and eliminate mycophenolic acid CellCept following their prescribed dose The results may lead to better dosing based on individual needs
Detailed Description:
This is an open-label inpatient-outpatient population pharmacokinetic-pharmacodynamic PK-PD study of mycophenolic acid MPA in pediatric subjects age 2-17 years who have had a recent kidney transplant as well as during the stable renal transplant period when on a stable oral regimen of MPA The primary objective of this study is to develop population pharmacokinetic-pharmacodynamic PK-PD models for mycophenolic acid MPA and mycophenolic acid glucuronide MPAG in order to improve individualized pediatric dosing Subjects will have been receiving CellCept as part of their clinical standard of care It is anticipated that the clinical portion of the study for each patient will be approximately six months post renal transplant with four study days a screening visit pre-transplant two 10-hour inpatient days at 2-3 and 6-9 days post-transplant and one up to 10 hour outpatient visit at 3-6 months post-transplant Pharmacokinetic and pharmacodynamic measurements will be conducted at various time points up to 9 hours post dose on study days 2 3 and 4 Safety data to be collected will include physical examinations measurement of vital signs and laboratory assessments 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CEL420 | None | None | None |