Advancing Transplantation Outcomes in Children

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.

Conditions

Kidney Transplant

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Study Overview

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Study Details

Study overview

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.

Advancing Transplantation Outcomes in Children (CTOT-41)

Advancing Transplantation Outcomes in Children

Condition
Kidney Transplant
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (Site # 71038), Birmingham, Alabama, United States, 35233

Los Angeles

Children's Hospital of Los Angeles (Site #: 71036), Los Angeles, California, United States, 90027

Los Angeles

Cedars-Sinai Medical Center (Site #: 71026), Los Angeles, California, United States, 90048

Los Angeles

Mattel Children's Hospital, UCLA (Site #: 71012), Los Angeles, California, United States, 90095

San Diego

UCSD Rady Children's Hospital (Site #: 71037), San Diego, California, United States, 92123

Aurora

Children's Hospital of Colorado (Site #: 71019), Aurora, Colorado, United States, 80045

Wilmington

Nemours Children's Health (Site #: 71042), Wilmington, Delaware, United States, 19803

Washington

Children's National Medical Center (Site #: 71039), Washington, District of Columbia, United States, 20010

Chicago

Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016), Chicago, Illinois, United States, 60611

Baltimore

Johns Hopkins Children's Center (Site #: 71025), Baltimore, Maryland, United States, 21287

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

13 Years to 20 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2028-11-01