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New treatment option for Kidney Transplant
Official title Advancing Transplantation Outcomes in Children
ClinicalTrials.gov ID: NCT06055608
What this study is testing
What is Sirolimus?
Sirolimus is an investigational medicine, given as an once-daily, being studied as a potential treatment for kidney transplant.
Also referred to as AY 22-989, Rapamune.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 20
You may be able to join if
- 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 living or 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...
- EBV VCA IgM seronegative OR EBV VCA IgM seropositive on two occasions at least 3 months apart and an undetectable EBV PCR result within 1 month prior...
You likely can't join if
- Inability or unwillingness to comply with study protocol
- Active infection requiring treatment, or viremia
- History of malignancy
- Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
- Prior history of organ transplantation
- Listed for multi-organ transplant (e.g. heart- kidney, liver-kidney, multivisceral- kidney, lung- kidney)
See the full eligibility criteria
- 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 living or 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)
- EBV VCA IgM seronegative OR EBV VCA IgM seropositive on two occasions at least 3 months apart and an undetectable EBV PCR result within 1 month prior to enrollment
- If a female participant of childbearing potential, a negative pregnancy test prior to conducting any study procedures
- 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)...
- 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...
- Inability or unwillingness to comply with study protocol
- Active infection requiring treatment, or viremia
- History of malignancy
- Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
- Prior history of organ transplantation
- Listed for multi-organ transplant (e.g. heart- kidney, liver-kidney, multivisceral- kidney, lung- kidney)
- 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
- Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or investigational drug(s) within 8 weeks of enrollment
- Known bleeding disorder
- Sustained platelet count \< 75,000 cells/microliters within 3 months of enrollment
- History of inherited hypercoagulability requiring therapy more than aspirin
- Panel Reactive Antibody (cPRA) greater than 80 percent
- Clinically significant unrepaired congenital heart disease causing hemodynamic compromise
- 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
- 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...
- Sustained WBC \ 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
- Sustained platelet count \< 75,000 cells/microliters within 3 months of enrollment
- Current (within 45 days) or historical anti-HLA antibody to the donor prior to randomization
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of randomization
- Panel Reactive Antibody (cPRA) greater than 80 percent at any point in time
- 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...
- Treatment with immunosuppressants within 8 weeks of randomization, except in the case of planned transplant standard of care
- Treatment with biologics (including IVIG) within 8 weeks of randomization
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Westchester, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; San Diego, California, United States; Aurora, Colorado, United States; Wilmington, Delaware, United States; Washington D.C., District of Columbia, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.