Advancing Transplantation Outcomes in Children
a study on Kidney Transplant Transplants
Summary
- Eligibility
- for people ages 13-20 (full criteria)
- Location
- at San Diego, California and other locations
- Dates
- study startedestimated completion
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
- Participant and/or parent/guardian must be able to understand and provide informed consent
- Male or female, 13-20 years of age at time of enrollment
- Candidate for primary renal allograft from a deceased donor
- 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
- If a female participant of childbearing potential, a negative pregnancy test within 48 hours of enrollment
- If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study
- 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
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...
- Inability or unwillingness to comply with study protocol
- Active infection requiring treatment, or viremia
- History of malignancy
- Current or historical anti-HLA antibody to the donor
- Peak calculated Panel Reactive Antibody (cPRA) greater than 80 percent
- Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
- Prior history of organ transplantation
- Active systemic autoimmune disease at time of enrollment
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.
- Sustained WBC <1500 or >20,000 per microliter within 3 months of randomization
- Sustained liver function tests (AST and/or ALT) > 2x normal within 3 months of randomization
- Active systemic autoimmune disease at time of transplant
- Known bleeding disorder
- Platelet count < 75,000 cells/microliters within 3 months of enrollment
- Current or historical anti-HLA antibody to the donor at the time of transplant
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of randomization
- Panel Reactive Antibody (cPRA) greater than 80 percent
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) Division of Allergy, Immunology, and Transplantation (DAIT)
- ID
- NCT06055608
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 200 study participants
- Last Updated