Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00166153
Recruitment Status : Terminated
First Posted : September 14, 2005
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):
Kirk R. Kanter, MD, Emory University

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 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.

Condition or disease Intervention/treatment Phase
Cardiac Transplantation Drug: Mycophenolate Mofetil Not Applicable

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 assessments/physical 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Relationships Between Mycophenolic Acid Levels, T-Cell Subsets and Outcomes in Pediatric Heat Transplant Recipients Receiving Mycophenolate Mofetil (Cellcept)
Study Start Date : January 2003
Study Completion Date : May 2005

Primary Outcome Measures :
  1. Examine t-cell subsets to determine the correlation between MIP levels and clinical outcome as well as effect on T-cell proliferation.

Secondary Outcome Measures :
  1. Examine histologic grading of routine endomyocardial biopsies to determine the correlation between MPS levels and acute rejections.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00166153

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Kirk Kanter, MD Emory University

Responsible Party: Kirk R. Kanter, MD, Principal Investigator, Emory University Identifier: NCT00166153     History of Changes
Other Study ID Numbers: 0685-2002
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Kirk R. Kanter, MD, Emory University:
cardiac transplantation
drug metabolism

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action