Summary

Eligibility
for people ages 13-20 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

Summary

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)

Keywords

Kidney Transplant, belatacept, sirolimus, Mycophenolic Acid, Abatacept, Tacrolimus, Antilymphocyte Serum, Mycophenolate Mofetil, Tacrolimus (Group1), Anti-Thymocyte Globulin (ATG), Tacrolimus (Group 2)

Eligibility

You can join if…

Open to people ages 13-20

  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) at time of enrollment
  5. If a female participant of childbearing potential, a negative pregnancy test within 48 hours of enrollment
  6. If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study
  7. 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
  8. 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

    Enrollment criteria for donor source and age will be expanded using a stepwise approach determined by safety monitoring. Expansion criteria will include recipients down to age 6 and living donors. Safety data from each step will be reviewed by the study team, DSMB and FDA. If no safety concerns are identified, inclusion criteria will be expanded.

You CAN'T join if...

  1. Inability or unwillingness to comply with study protocol
  2. Active infection requiring treatment, or viremia
  3. History of malignancy
  4. Current or historical anti-HLA antibody to the donor
  5. Peak calculated Panel Reactive Antibody (cPRA) greater than 80 percent
  6. Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
  7. Prior history of organ transplantation
  8. Active systemic autoimmune disease at time of enrollment
  9. Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence

    10. Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or

    investigational drug(s) within 8 weeks of enrollment

    11. Known bleeding disorder 12. Platelet count < 75,000 cells/microliters within 3 months of enrollment 13. History of inherited hypercoagulability requiring therapy more than aspirin 14. Clinically significant unrepaired congenital heart disease causing hemodynamic

    compromise

    15. 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

    16. 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

    Randomization Exclusion Criteria: Individuals who meet any of these criteria are not eligible for randomization.

  10. Sustained WBC <1500 or >20,000 per microliter within 3 months of randomization
  11. Sustained liver function tests (AST and/or ALT) > 2x normal within 3 months of randomization
  12. Active systemic autoimmune disease at time of transplant
  13. Known bleeding disorder
  14. Platelet count < 75,000 cells/microliters within 3 months of enrollment
  15. Current or historical anti-HLA antibody to the donor at the time of transplant
  16. Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of randomization
  17. Panel Reactive Antibody (cPRA) greater than 80 percent
  18. If a female participant of childbearing potential, a positive pregnancy test within 48 hours of randomization (all female participants of childbearing potential must complete a pregnancy test within 48 hours of randomization)

    10. Treatment with immunosuppressants, including biologics (including IVIG), within 8

    weeks of randomization

Locations

  • University of California San Diego, Rady Children's Hospital: Pediatric Transplantation
    San Diego California 92123 United States
  • Ronald Reagan UCLA Medical Center: Pediatric Transplantation
    Los Angeles California 90095 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT06055608
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated