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Cardiac TransplantationNCT00166153

Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept

A study testing Mycophenolate Mofetil in people with Cardiac Transplantation, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 weeks to 18 years
Conditions the study is for
Cardiac Transplantation
What is being tested?
Mycophenolate Mofetil
How many people
30 participants
Where
1 siteUnited States
Study dates
Jan 2003to May 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 weeks to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: The Relationships Between Mycophenolic Acid Levels, T-Cell Subsets and Outcomes in Pediatric Heat Transplant Recipients Receiving Mycophenolate Mofetil (Cellcept)

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.

Read the 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.

Keywords
cardiac transplantation, pediatrics, cardiology, drug metabolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startJan 2003
  3. Study completionMay 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00166153
Sponsor's protocol ID
0685-2002
Status last verified
Nov 2013
First submitted
12 Sep 2005
Last updated
21 Nov 2013
Results posted
No

Publications

  • 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.

    PubMed 11038624

  • 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.

    PubMed 11391040

  • 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.

    PubMed 7955282

  • 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.

    PubMed 11595558

  • 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.

    PubMed 11591897

Questions about this trial

What is this clinical trial studying?

A study testing Mycophenolate Mofetil in people with Cardiac Transplantation, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Examine t-cell subsets to determine the correlation between MIP levels and clinical outcome as well as effect on T-cell proliferation.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00166153, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.

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