Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
290 participants
OBSERVATIONAL
2010-01-31
2014-12-31
Brief Summary
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Detailed Description
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This study plans to enroll 370 pediatric heart transplant recipients over a period of 3 years. The follow-up period will last up to 3 years. All participants will be enrolled pretransplant. In the pretransplant phase, visits will occur every 6 months. These routine visits will continue until transplant or the end of the study. They will coincide with routine pretransplant status visits. At the time of transplant, the participants will be assigned to one of two groups. Group A will include participants who are allo-antibody negative (less than 10% by AHG CDC-PRA and ELISA in all DTT-treated serum samples). Cohort B will include participants who have the presence of a DTT-treated AHG CDC-PRA of greater than or equal to 10% and/or an ELISA-PRA greater than or equal to 10% in any pretransplant sample.
Both cohorts will receive standard transplantation care. This study has no interventions. All participants will undergo regular blood tests, and, those in the sensitized group will have additional blood testing performed after the transplant and lasting until the end of the study. Post-transplant visits will occur while participants are recovering in the hospital; at Months 1, 3, and 6; and annually until the study closes.
The information collected for the study include data from a physical exam, routine testing, adverse (AEs) and serious adverse (SAEs) events assessments, and blood collection. Each time a biopsy is done, the study will ask to review the biopsy tissue and to collect a sample. If stored tissue is not available, none will be collected.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A: Non-Sensitized
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®).
Induction Therapy
Per standard of care guidelines for immunosuppression at each clinical site.
Tacrolimus
Per standard of care guidelines for immunosuppression at each clinical site.
Mycophenolate Mofetil
Per standard of care guidelines for immunosuppression at each clinical site.
Cohort B: Sensitized
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®).
Induction Therapy
Per standard of care guidelines for immunosuppression at each clinical site.
Tacrolimus
Per standard of care guidelines for immunosuppression at each clinical site.
Mycophenolate Mofetil
Per standard of care guidelines for immunosuppression at each clinical site.
Intraoperative plasma exchange/pheresis
Per standard of care guidelines for immunosuppression at each clinical site.
Short-term post-operative plasmapheresis
Per standard of care guidelines for immunosuppression at each clinical site.
Immunoglobulins, Intravenous
Post-transplant course of intravenous immunoglobulin therapy per standard of care guidelines for immunosuppression at each clinical site.
Prednisone
Maintenance corticosteroids per standard of care guidelines for immunosuppression at each clinical site.
Interventions
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Induction Therapy
Per standard of care guidelines for immunosuppression at each clinical site.
Tacrolimus
Per standard of care guidelines for immunosuppression at each clinical site.
Mycophenolate Mofetil
Per standard of care guidelines for immunosuppression at each clinical site.
Intraoperative plasma exchange/pheresis
Per standard of care guidelines for immunosuppression at each clinical site.
Short-term post-operative plasmapheresis
Per standard of care guidelines for immunosuppression at each clinical site.
Immunoglobulins, Intravenous
Post-transplant course of intravenous immunoglobulin therapy per standard of care guidelines for immunosuppression at each clinical site.
Prednisone
Maintenance corticosteroids per standard of care guidelines for immunosuppression at each clinical site.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability or unwillingness of the participant or parent/guardian to give written informed consent or comply with the study protocol
* Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete at least one year of follow-up
* Current participation in other research studies that would, or might, interfere with the scientific integrity or safety of current study (e.g. by interference with immunosuppression management guidelines, study endpoints, excessive blood draws or SAE evaluation).
21 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Stephen A. Webber, MBChB, MRCP
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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Children's Hospital Boston, Harvard Medical School
Boston, Massachusetts, United States
St. Louis Children's Hospital, Washington University
St Louis, Missouri, United States
Children's Hospital of New York, Columbia University Medical Center
New York, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Children's Hospital of Philadelphia, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Hospital for Sick Children, Labatt Family Heart Centre
Toronto, Ontario, Canada
Countries
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References
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Rose ML, Smith JD. Clinical relevance of complement-fixing antibodies in cardiac transplantation. Hum Immunol. 2009 Aug;70(8):605-9. doi: 10.1016/j.humimm.2009.04.016. Epub 2009 Apr 16.
Patel R, Terasaki PI. Significance of the positive crossmatch test in kidney transplantation. N Engl J Med. 1969 Apr 3;280(14):735-9. doi: 10.1056/NEJM196904032801401. No abstract available.
Lamour JM, Mason KL, Hsu DT, Feingold B, Blume ED, Canter CE, Dipchand AI, Shaddy RE, Mahle WT, Zuckerman WA, Bentlejewski C, Armstrong BD, Morrison Y, Diop H, Ikle DN, Odim J, Zeevi A, Webber SA; CTOTC-04 investigators. Early outcomes for low-risk pediatric heart transplant recipients and steroid avoidance: A multicenter cohort study (Clinical Trials in Organ Transplantation in Children - CTOTC-04). J Heart Lung Transplant. 2019 Sep;38(9):972-981. doi: 10.1016/j.healun.2019.06.006. Epub 2019 Jun 20.
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID) website
National Heart Lung and Blood Institute (NHLBI) website
Clinical Trials in Organ Transplantation in Children (CTOT-C) website
Other Identifiers
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DAIT CTOTC-04
Identifier Type: -
Identifier Source: org_study_id
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