Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept

NCT00166153 | Terminated

• 1 other identifier: 0685-2002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Transplantation

Keywords

cardiac transplantation; pediatrics; cardiology; drug metabolism

Outcome Measures

Primary Outcomes (1)

• Examine t-cell subsets to determine the correlation between MIP levels and clinical outcome as well as effect on T-cell proliferation.

Secondary Outcomes (1)

• Examine histologic grading of routine endomyocardial biopsies to determine the correlation between MPS levels and acute rejections.

Interventions

Mycophenolate Mofetil DRUG

Eligibility Criteria

• Age: 2 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.)

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (5)

• Keck BM, Bennett LE, Rosendale J, Daily OP, Novick RJ, Hosenpud JD. Worldwide thoracic organ transplantation: a report from the UNOS/ISHLT International Registry for Thoracic Organ Transplantation. Clin Transpl. 1999:35-49.

  PMID: 11038624 BACKGROUND

• Laks H, Marelli D, Odim J, Fazio D. Heart transplantation in the young and elderly. Heart Fail Rev. 2001 Sep;6(3):221-6. doi: 10.1023/a:1011406022657.

  PMID: 11391040 BACKGROUND

• Sarris GE, Smith JA, Bernstein D, Griffin ML, Pitlick PT, Baum D, Billingham ME, Oyer PE, Stinson EB, Starnes VA, et al. Pediatric cardiac transplantation. The Stanford experience. Circulation. 1994 Nov;90(5 Pt 2):II51-5.

  PMID: 7955282 BACKGROUND

• Dipchand AI, Pietra B, McCrindle BW, Rosebrook-Bicknell HL, Boucek MM. Mycophenolic acid levels in pediatric heart transplant recipients receiving mycophenolate mofetil. J Heart Lung Transplant. 2001 Oct;20(10):1035-43. doi: 10.1016/s1053-2498(01)00305-9.

  PMID: 11595558 BACKGROUND

• Morissette P, Albert C, Busque S, St-Louis G, Vinet B. In vivo higher glucuronidation of mycophenolic acid in male than in female recipients of a cadaveric kidney allograft and under immunosuppressive therapy with mycophenolate mofetil. Ther Drug Monit. 2001 Oct;23(5):520-5. doi: 10.1097/00007691-200110000-00004.

  PMID: 11591897 BACKGROUND

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Kirk Kanter, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: January 1, 2003
• Study Completion: May 1, 2005
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

US (1)