RECRUITING

Advancing Transplantation Outcomes in Children

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Official Title

Advancing Transplantation Outcomes in Children (CTOT-41)

Quick Facts

Study Start:2024-05-22

Study Completion:2028-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06055608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 20 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Participant and/or parent/guardian must be able to understand and provide informed consent 2. Male or female, 13-20 years of age at time of enrollment 3. Candidate for primary renal allograft from a deceased donor 4. EBV IgG seropositive, defined as evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA) 5. EBV VCA IgM seronegative 6. If a female participant of childbearing potential, a negative pregnancy test within 48 hours of enrollment 7. If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study 8. Negative test result for latent tuberculosis infection by tuberculosis skin test (purified protein derivative \[PPD\]) or Tuberculosis (TB) blood test (interferon gamma release assay \[IGRA\] i.e., QuantiFERON, T- SPOT.TB) within 12 months 9. In the absence of contraindication, vaccinations must be up to date per the Centers for Disease Control and Prevention (CDC) Guidelines and Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials	1. Inability or unwillingness to comply with study protocol 2. Active infection requiring treatment, or viremia 3. History of malignancy 4. Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment 5. Prior history of organ transplantation 6. Active systemic autoimmune disease at time of enrollment 7. Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence 8. Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or investigational drug(s) within 8 weeks of enrollment 9. Known bleeding disorder 10. Sustained platelet count \< 75,000 cells/microliters within 3 months of enrollment 11. History of inherited hypercoagulability requiring therapy more than aspirin 12. Clinically significant unrepaired congenital heart disease causing hemodynamic compromise 13. Uncontrolled diagnosed psychiatric disorder or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements 14. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Inclusion Criteria

Exclusion Criteria

1. Participant and/or parent/guardian must be able to understand and provide informed consent
2. Male or female, 13-20 years of age at time of enrollment
3. Candidate for primary renal allograft from a deceased donor
4. EBV IgG seropositive, defined as evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA)
5. EBV VCA IgM seronegative
6. If a female participant of childbearing potential, a negative pregnancy test within 48 hours of enrollment
7. If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study
8. Negative test result for latent tuberculosis infection by tuberculosis skin test (purified protein derivative \[PPD\]) or Tuberculosis (TB) blood test (interferon gamma release assay \[IGRA\] i.e., QuantiFERON, T- SPOT.TB) within 12 months
9. In the absence of contraindication, vaccinations must be up to date per the Centers for Disease Control and Prevention (CDC) Guidelines and Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials

1. Inability or unwillingness to comply with study protocol
2. Active infection requiring treatment, or viremia
3. History of malignancy
4. Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
5. Prior history of organ transplantation
6. Active systemic autoimmune disease at time of enrollment
7. Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence
8. Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or investigational drug(s) within 8 weeks of enrollment
9. Known bleeding disorder
10. Sustained platelet count \< 75,000 cells/microliters within 3 months of enrollment
11. History of inherited hypercoagulability requiring therapy more than aspirin
12. Clinically significant unrepaired congenital heart disease causing hemodynamic compromise
13. Uncontrolled diagnosed psychiatric disorder or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
14. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Contacts and Locations

Principal Investigator

David Briscoe, MD

STUDY_CHAIR

Boston Children's Hospital: Pediatric Transplantation

Eileen Chambers, MD

STUDY_CHAIR

Duke University Medical Center: Department of Pediatrics

Study Locations (Sites)

University of Alabama at Birmingham (Site # 71038)

Birmingham, Alabama, 35233

United States

Children's Hospital of Los Angeles (Site #: 71036)

Los Angeles, California, 90027

United States

Cedars-Sinai Medical Center (Site #: 71026)

Los Angeles, California, 90048

United States

Mattel Children's Hospital, UCLA (Site #: 71012)

Los Angeles, California, 90095

United States

UCSD Rady Children's Hospital (Site #: 71037)

San Diego, California, 92123

United States

Children's Hospital of Colorado (Site #: 71019)

Aurora, Colorado, 80045

United States

Nemours Children's Health (Site #: 71042)

Wilmington, Delaware, 19803

United States

Children's National Medical Center (Site #: 71039)

Washington, District of Columbia, 20010

United States

Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016)

Chicago, Illinois, 60611

United States

Johns Hopkins Children's Center (Site #: 71025)

Baltimore, Maryland, 21287

United States

Boston Children's Hospital (Site #: 71001)

Boston, Massachusetts, 02215

United States

Helen DeVos Children's Hospital (Site #: 71035)

Grand Rapids, Michigan, 49503

United States

Washington University/St. Louis Children's Hospital (Site #: 71006)

Saint Louis, Missouri, 63110

United States

New York Medical College/Boston Children's Health Physicians

Westchester, New York, 10461

United States

Duke University (Site #: 71033)

Durham, North Carolina, 27710

United States

Cincinnati Children's Hospital Medical Center (Site #: 71017)

Cincinnati, Ohio, 45229

United States

Children's Hospital of Philadelphia (Site #: 71091)

Philadelphia, Pennsylvania, 19104

United States

UPMC Children's Hospital of Pittsburgh (Site #: 71008)

Pittsburgh, Pennsylvania, 15224

United States

Texas Children's Hospital (Baylor) (Site #: 71005)

Houston, Texas, 77030

United States

Seattle Children's Hospital (Site #: 71041)

Seattle, Washington, 98105

United States

Collaborators and Investigators

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

David Briscoe, MD, STUDY_CHAIR, Boston Children's Hospital: Pediatric Transplantation
Eileen Chambers, MD, STUDY_CHAIR, Duke University Medical Center: Department of Pediatrics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-22

Study Completion Date2028-11-01

Study Record Updates

Study Start Date2024-05-22

Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

kidney transplant
belatacept
sirolimus

Additional Relevant MeSH Terms

Kidney Transplant