Alloantibodies in Pediatric Heart Transplantation

Recruiting in St. Louis (>99 mi)

+7 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the clinical outcomes of sensitized pediatric heart transplant recipients with a positive donor-specific cytotoxicity crossmatch and to compare this group with outcomes in nonsensitized heart transplant recipients.

Research Team

Stephen A. Webber, MBChB, MRCP

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

All participants listed for heart transplantation at participating CTOT-C study sites.

Treatment Details

Interventions

• Immunoglobulins, Intravenous (Immunoglobulin)
• Intraoperative plasma exchange/pheresis (Procedure)
• Mycophenolate Mofetil (Immunosuppressant)
• Prednisone (Corticosteroid)
• Short-term post-operative plasmapheresis (Procedure)
• Tacrolimus (Immunosuppressant)

Participant Groups

Group I: Cohort B: Sensitized Experimental Treatment 7 Interventions

Cohort B will include participants who are alloantibody positive (Sensitized) as determined by Luminex LabScreen for Class I or Class II with specificities identified by single antigen testing. There is no study mandated care or treatment. All care given is clinical site standard of care. All sites follow a similar standard of care regimen. Sensitized recipients receive: 1. Induction Therapy (anti-T cell antibody induction) 2. Intraoperative plasma exchange/pheresis 3. Short-term post-operative plasmapheresis 4. Post-transplant course of intravenous immunoglobulin (IVIG) therapy 5. Maintenance corticosteroids (Prednisone) 6. Tacrolimus (Prograf®) 7. Mycophenolate Mofetil-MMF (CellCept®).

Group II: Cohort A: Non-Sensitized Experimental Treatment 3 Interventions

Cohort A will include participants who are alloantibody Luminex(TM) LABScreen. There is no study mandated care or treatment. All care given is clinical site standard of care. All sites follow a similar standard of care regimen. Non-sensitized recipients receive steroid-free maintenance immunosuppression: 1. Induction Therapy (anti-T cell antibody induction) 2. Tacrolimus (Prograf®) 3. Mycophenolate Mofetil- MMF (CellCept®).

Mycophenolate Mofetil is already approved in Canada, Japan for the following indications:

Approved in Canada as Cellcept for:

• Prevention of acute organ rejection in kidney, liver, and heart transplant patients
• Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis

Approved in Japan as Cellcept for:

• Prevention of acute organ rejection in kidney, liver, and heart transplant patients
• Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Hospital of Philadelphia, University of Pennsylvania Philadelphia, PA

Vanderbilt University Nashville, TN

Children's Hospital of Pittsburgh of UPMC Pittsburgh, PA

Children's Hospital of New York, Columbia University Medical Center New York, NY

More Trial Locations

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3361

Recruited

5,516,000+

H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Deputy Director for Clinical Research and Special Projects since 2023

M.D.

Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Director since 2023

M.D., M.P.H.

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Recruited

47,860,000+

Zachariah McIver

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer

D.O. from Ohio University College of Osteopathic Medicine, Ph.D. in Molecular Medicine and Translational Sciences from Wake Forest University School of Medicine

James F. Holmes

National Heart, Lung, and Blood Institute (NHLBI)

Co-Principal Investigator, National Heart, Lung, and Blood Institute K12 Program since 2011

MD from the University of Alabama, School of Medicine