Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept

Stopped early · Not applicable

Conditions studied: Cardiac Transplantation

In brief

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 patient's 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.

Key facts

Study ID

NCT00166153

Run by

Emory University

People needed

30

Starts

2003-01-01

Expected to finish

2005-05-01

Last updated by the study team

2013-11-21

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heart Transplant Recipients who are transplanted during the course of this study.
• Age 2 weeks to 18 years
• Receiving or plan to receive Mycophenolate mofetil therapy
• Patient/Family has signed an informed assent/consent

You may not qualify if…

• Patients that are unable to follow protocol schedule of assessment
• Patients with chronic autoimmune disease
• Patients who have received a multiple organ transplant (i.e. heart-liver, heart-lung etc.)

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.