Pediatric Heart TransplantationNCT01005316
Alloantibodies in Pediatric Heart Transplantation
An observational study of Pediatric Heart Transplantation and Pediatric Heart Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pediatric Heart Transplantation, Pediatric Heart Transplant Recipients
- What is being tested?
- Induction Therapy, Tacrolimus and Mycophenolate Mofetil
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 290 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2010to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric heart transplantation candidates
Who may be able to join
- All participants listed for heart transplantation at participating CTOT-C study sites.
Who cannot join
- Listed for multiple organ transplant
- 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).
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Children's Hospital Boston, Harvard Medical School
Boston, Massachusetts, 02115
Vanderbilt University
Nashville, Tennessee, 37232
Children's Hospital of New York, Columbia University Medical Center
New York, New York, 10032
Children's Hospital of Philadelphia, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
St. Louis Children's Hospital, Washington University
St Louis, Missouri, 63110
Children's Hospital at Montefiore
The Bronx, New York, 10467
Canada1 site
Hospital for Sick Children, Labatt Family Heart Centre
Toronto, Ontario, M5G 1X8
About this study
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.
Read the detailed description
There is currently a renewed interest in alloantibodies in transplantation. In 1966, Kissmeyer and colleagues reported that pre-existing antibodies directed against donor cells could cause hyperacute rejection of the renal allograft. Three years later, in a landmark study, Patel and Terasaki showed that a lymphocytotoxic assay to identify donor-specific antibodies was highly predictive of acute graft failure. These observations led to the practice of performing prospective, donor-specific crossmatches by lymphocytotoxicity assay for all kidney transplants and for heart and lung transplants when the candidate has a positive panel reactive antibody (PRA) assay. A concept evolved that transplantations should not be performed across a positive cytotoxicity crossmatch. 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.
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.
- Being tested
- Induction Therapy, Tacrolimus, Mycophenolate Mofetil, Intraoperative plasma exchange/pheresis, Short-term post-operative plasmapheresis
- Keywords
- cohort study, allo-antibodies, allosensitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction TherapyDrug
Also called anti-T cell antibody induction
Per standard of care guidelines for immunosuppression at each clinical site.
TacrolimusDrug
Also called Prograf®
Per standard of care guidelines for immunosuppression at each clinical site.
Also called CellCept®, MMF
Per standard of care guidelines for immunosuppression at each clinical site.
Intraoperative plasma exchange/pheresisProcedure or surgery
Also called plasmapheresis
Per standard of care guidelines for immunosuppression at each clinical site.
Short-term post-operative plasmapheresisProcedure or surgery
Also called pheresis
Per standard of care guidelines for immunosuppression at each clinical site.
Immunoglobulins, IntravenousDrug
Also called IVIG
Post-transplant course of intravenous immunoglobulin therapy per standard of care guidelines for immunosuppression at each clinical site.
PrednisoneDrug
Also called corticosteroid
Maintenance corticosteroids per standard of care guidelines for immunosuppression at each clinical site.
| Study group | Role | What they receive |
|---|---|---|
| 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®). Receives: Drug: Induction Therapy; Drug: Tacrolimus; Drug: Mycophenolate Mofetil | |
| 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®). Receives: Drug: Induction Therapy; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Procedure: Intraoperative plasma exchange/pheresis; Procedure: Short-term post-operative plasmapheresis; Drug: Immunoglobulins, Intravenous; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation
This is a composite outcome of death, graft loss or rejection with hemodynamic compromise.
Rejection was considered to be with hemodynamic compromise if the rejection event had new onset echocardiographically measured from fractional shortening <26% with ≥5% fall from last echocardiogram or the rejection event had new onset of heart failure.
Measured: 12 months post-transplantation
Secondary outcomes (16)
Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies
Time (in days) from transplant to development of de novo donor-specific alloantibodies (DSA). This measure is calculated as time from transplant until the earliest time of development of any de novo DSA. The DSA is a newly developed alloantibody that is against the donor organ. Alloantibodies are important mediators of acute and chronic rejection.
Measured: Transplantation to first year post transplant (up to 12 months post transplant).
Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation
A de novo donor-specific alloantibody (DSA) is a newly developed alloantibody that is against the donor organ. This measure includes all de novo DSA (≥1000 MFI) regardless of is persistence or timing within the first year post-transplant. Alloantibodies are important mediators of acute and chronic rejection.
Measured: Transplantation to first year post transplant (up to 12 months post transplant).
Percentage of Participants- Mortality While on Transplantation Wait-List
Death that occurred while on the transplantation wait-list, and thus before receiving a heart transplant.
Measured: Pre-transplantation
Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing
Time (in days) from listing on the organ wait-list to receiving an organ transplant, death or de-listing. This measure is calculated as time from listing on the organ wait-list until the earliest time among transplantation, death and de-listing.
Measured: Study enrollment to transplantation
Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing
Luminex SA testing was used to detect the presence of anti-HLA IgG Antibodies for all samples at a central laboratory.
Measured: Pre-transplantation
Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing
Quantification of anti-HLA IgG antibodies is measured in mean fluorescence intensity (MFI). The maximum MFI for the given subject is provided.
Measured: Pre-transplantation
Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay
Major histocompatibility complex class I chain-related gene A (MICA) is an antigen that is a potential marker of rejection. Luminex TM assay was used to detect its presence.
Measured: Pre-Transplantation
Percentage of Participants -Overall Participant and Graft Survival
This measure looks at the participants who did not die and/or did not receive a subsequent heart transplant.
Measured: Transplantation to the end of study (up to 4 years post transplant).
Presence of C4d on Endomyocardial Biopsy (EMB)
The biopsy of the heart stained positive for the presence of C4d, a potential marker of rejection.
Measured: Transplantation to the end of study (up to 4 years post transplant).
Percentage of Participants With Occurrence of Re-Hospitalization(s)
Hospitalization is defined as any hospitalization lasting greater than 24 hours.
Measured: Transplantation to the end of study (up to 4 years post transplant).
Percentage of Participants Positive for Severe Infection(s)
Severe infections are defined as a clinical illness considered likely infectious in origin that leads to hospitalization.
Measured: Transplantation to the end of study (up to 4 years post transplant).
Time to Diagnosis of Chronic Rejection
Time (in days) to the diagnosis of chronic rejection. Chronic rejection is defined as stenosis, irregularity, or ectasia of the epicardial vessels, or severe peripheral pruning of the distal coronary artery tree. Time to diagnosis is time from transplantation until the first diagnosis of chronic rejection.
Measured: Transplantation to the end of study (up to 4 years post transplant).
Time to Post-Transplantation Lymphoproliferative Disorder
Time (in days) post-transplant lymphoproliferative disorder (PTLD). PTLD is defined as histopathological evidence of lymphoid proliferation (nodal or extranodal) fulfilling the criteria of the revised classification of the WHO 2008 (Swerdlow 2008). Time to PTLD is time from transplantation until the diagnosis of PTLD.
Measured: Transplantation to the end of study (up to 4 years post transplant).
Time to New-Onset Diabetes Mellitus
Time (in days) to new-onset diabetes mellitus. New-onset diabetes mellitus is defined as the new onset of insulin dependency or the need for oral hypoglycemic agents lasting more than 30 days post-transplant. Time to new-onset diabetes is time from transplantation until the diagnosis of new-onset diabetes.
Measured: Transplantation to the end of study (up to 4 years post transplant).
Percentage of Participants Experiencing Acute Rejection
Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT)) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression).
Measured: Transplantation to the end of study.
Time to Acute Rejection
Time (in days) to acute rejection. Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression). Time to acute rejection is time from transplantation to first acute rejection date.
Measured: Transplantation to the end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Inability to meet accrual goals within the funding period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Heart TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stephen A. Webber, MBChB, MRCP, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005316
- Sponsor's protocol ID
- DAIT CTOTC-04
- Other IDs
- 7U01AI077867-02
- Status last verified
- Mar 2017
- First submitted
- 27 Oct 2009
- Last updated
- 20 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19375471Patel 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.
PubMed 4886455Lamour 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.
PubMed 31324444
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alloantibodies in Pediatric Heart Transplantation
- ClinicalTrials.gov ID
- NCT01005316
- Acronym / sponsor ID
- DAIT CTOTC-04
- Keywords
- cohort study, allo-antibodies, allosensitization
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to meet accrual goals within the funding period.
- Enrolment
- 290 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 20 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is currently a renewed interest in alloantibodies in transplantation. In 1966, Kissmeyer and colleagues reported that pre-existing antibodies directed against donor cells could cause hyperacute rejection of the renal allograft. Three years later, in a landmark study, Patel and Terasaki showed that a lymphocytotoxic assay to identify donor-specific antibodies was highly predictive of acute graft failure. These observations led to the practice of performing prospective, donor-specific crossmatches by lymphocytotoxicity assay for all kidney transplants and for heart and lung transplants when the candidate has a positive panel reactive antibody (PRA) assay. A concept evolved that transplantations should not be performed across a positive cytotoxicity crossmatch. 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Non-Sensitized | – | Drug: Induction Therapy, Drug: Tacrolimus, Drug: Mycophenolate MofetilCohort 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®). |
| Cohort B: Sensitized | – | Drug: Induction Therapy, Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Procedure: Intraoperative plasma exchange/pheresis, Procedure: Short-term post-operative plasmapheresis, Drug: Immunoglobulins, Intravenous, Drug: PrednisoneCohort 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®). |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric heart transplantation candidates
Key inclusion criteria (1 listed)
- All participants listed for heart transplantation at participating CTOT-C study sites.
Key exclusion criteria (4 listed)
- Listed for multiple organ transplant
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction TherapyAlso: anti-T cell antibody inductionPer standard of care guidelines for immunosuppression at each clinical site. | Drug | Cohort A: Non-Sensitized, Cohort B: Sensitized |
| TacrolimusAlso: Prograf®Per standard of care guidelines for immunosuppression at each clinical site. | Drug | Cohort A: Non-Sensitized, Cohort B: Sensitized |
| Mycophenolate MofetilAlso: CellCept®, MMFPer standard of care guidelines for immunosuppression at each clinical site. | Drug | Cohort A: Non-Sensitized, Cohort B: Sensitized |
| Intraoperative plasma exchange/pheresisAlso: plasmapheresisPer standard of care guidelines for immunosuppression at each clinical site. | Procedure or surgery | Cohort B: Sensitized |
| Short-term post-operative plasmapheresisAlso: pheresisPer standard of care guidelines for immunosuppression at each clinical site. | Procedure or surgery | Cohort B: Sensitized |
| Immunoglobulins, IntravenousAlso: IVIGPost-transplant course of intravenous immunoglobulin therapy per standard of care guidelines for immunosuppression at each clinical site. | Drug | Cohort B: Sensitized |
| PrednisoneAlso: corticosteroidMaintenance corticosteroids per standard of care guidelines for immunosuppression at each clinical site. | Drug | Cohort B: Sensitized |
Primary outcome
Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation
Time frame: 12 months post-transplantation
This is a composite outcome of death, graft loss or rejection with hemodynamic compromise. Rejection was considered to be with hemodynamic compromise if the rejection event had new onset echocardiographically measured from fractional shortening <26% with ≥5% fall from last echocardiogram or the rejection event had new onset of heart failure.
16 secondary outcomes
Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies
Time frame: Transplantation to first year post transplant (up to 12 months post transplant).
Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation
Time frame: Transplantation to first year post transplant (up to 12 months post transplant).
Percentage of Participants- Mortality While on Transplantation Wait-List
Time frame: Pre-transplantation
Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing
Time frame: Study enrollment to transplantation
Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing
Time frame: Pre-transplantation
Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing
Time frame: Pre-transplantation
Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay
Time frame: Pre-Transplantation
Percentage of Participants -Overall Participant and Graft Survival
Time frame: Transplantation to the end of study (up to 4 years post transplant).
Presence of C4d on Endomyocardial Biopsy (EMB)
Time frame: Transplantation to the end of study (up to 4 years post transplant).
Percentage of Participants With Occurrence of Re-Hospitalization(s)
Time frame: Transplantation to the end of study (up to 4 years post transplant).
Percentage of Participants Positive for Severe Infection(s)
Time frame: Transplantation to the end of study (up to 4 years post transplant).
Time to Diagnosis of Chronic Rejection
Time frame: Transplantation to the end of study (up to 4 years post transplant).
Time to Post-Transplantation Lymphoproliferative Disorder
Time frame: Transplantation to the end of study (up to 4 years post transplant).
Time to New-Onset Diabetes Mellitus
Time frame: Transplantation to the end of study (up to 4 years post transplant).
Percentage of Participants Experiencing Acute Rejection
Time frame: Transplantation to the end of study.
Time to Acute Rejection
Time frame: Transplantation to the end of study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19375471Rose 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.
- Background: PubMed 4886455Patel 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.
- Derived from this study: PubMed 31324444Lamour 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.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- National Heart Lung and Blood Institute (NHLBI) websiteLink provided by the sponsor.
- Clinical Trials in Organ Transplantation in Children (CTOT-C) websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A. Webber, MBChB, MRCP study chair
University of Pittsburgh
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Heart Transplantation and Pediatric Heart Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in 2 countries.
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 1 inclusion and 4 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 20 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation (time frame: 12 months post-transplantation). 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 NCT01005316, which also lists 3 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 20 Apr 2017.