Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166153
Status:
TERMINATED
Last Update Posted:
2013-11-21
First Post:
2005-09-12
Brief Title:
Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
The Relationships Between Mycophenolic Acid Levels T-Cell Subsets and Outcomes in Pediatric Heat Transplant Recipients Receiving Mycophenolate Mofetil Cellcept
Status:
TERMINATED
Status Verified Date:
2013-11
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 survival of children who have received heart transplants has greatly improved over the last ten years One reason for this is better control over rejection Rejection medications require a delicate balance of enough medicine to work without causing side effects It is a goal to avoid both rejection and side effects from the anti-rejection medicines Usually several medicines are used together to prevent rejection One of these medicines is often Mycophenolic Acid or CellceptThis medicine has been used longer for adults than is has for children More information is needed on using it for children The dose is usually determined by the patients weight or body surface area
There have been some early studies of the use of Cellcept but none have proven a relationship between the blood level of the drug and how well it works More also needs to be known about how this drug works with other anti-rejection drugs and how it works in boys and girls This study will look more closely at proper dosing how Cellcept works with other anti-rejection medications side effects and any differences in how this medicine works in boys and girls
All patients in the study will be receiving Cellcept and have blood levels of the drug drawn Results of their usual treatment and testing will be recorded and evaluated for signs of rejection All the information will be analyzed Results of this study will be reported to transplant committees locally and nationally
There have been some early studies of the use of Cellcept but none have proven a relationship between the blood level of the drug and how well it works More also needs to be known about how this drug works with other anti-rejection drugs and how it works in boys and girls This study will look more closely at proper dosing how Cellcept works with other anti-rejection medications side effects and any differences in how this medicine works in boys and girls
All patients in the study will be receiving Cellcept and have blood levels of the drug drawn Results of their usual treatment and testing will be recorded and evaluated for signs of rejection All the information will be analyzed Results of this study will be reported to transplant committees locally and nationally
Detailed Description:
Pediatric heart transplant recipients receiving MMF will undergo study testing to measure MPA levels by the HPLC method and T-cell subsets by flow cytometry method As standard of care they receive histological grading of routine endomyocardial biopsies using the International Society of Heart Lung Transplantation ISHLT grading scale The data obtained from standard assessments will include medications echocardiographic reports pre-and post biopsy assessmentsphysical exams hospital records for any inpatient hospitalization and any laboratory assessments Also information will be collected on all patients which will be examined for tolerance and success side effects and rejection of immunosuppressive therapy
In newly transplanted patients study testing will occur at the same time as standard of care biopsies which are typically 1 week 2 weeks 3 weeks 4 weeks 6 weeks 8 weeks 3 months 4 months 5 months 6 months 8 months 10 months 12 months If the patient has additional visits due to rejection or changes in immunosuppression then more frequent study testing may be done per investigator preference Previously transplanted patients will have study testing at the same time as their standard of care visits usually annually
In newly transplanted patients study testing will occur at the same time as standard of care biopsies which are typically 1 week 2 weeks 3 weeks 4 weeks 6 weeks 8 weeks 3 months 4 months 5 months 6 months 8 months 10 months 12 months If the patient has additional visits due to rejection or changes in immunosuppression then more frequent study testing may be done per investigator preference Previously transplanted patients will have study testing at the same time as their standard of care visits usually annually
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