Advancing Transplantation Outcomes in Children: Kidney Transplant Study
This study is for young people aged 13 to 20 who are having a kidney transplant. It compares two different combinations of medicines used after transplant to prevent the body from rejecting the new kidney. One group will receive belatacept and sirolimus, while the other will receive tacrolimus and Mycophenolate Mofetil (MMF). Researchers want to see if one combination is safer and more effective at preventing problems like the body making antibodies against the new kidney or a decline in kidney function. You would need to have had a past infection with Epstein-Barr virus (EBV) to join. The study plans to enroll 200 participants and will follow them for 12 to 24 months after their transplant.
- Study design
- This is an interventional study where 200 participants will be randomly assigned to one of two treatment groups after their kidney transplant.
- What's involved
- Participants will receive specific immunosuppressant medications (sirolimus, belatacept, Mycophenolate Mofetil, tacrolimus, Anti-Thymocyte Globulin) according to their assigned group for up to 24 months. The study duration from transplant to the primary endpoint is 12-24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 to 24 months after their transplant, with the primary endpoints measured at 96 weeks post-transplant.
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Advancing Transplantation Outcomes in Children
At a glance
Conditions
NCT06055608
Where you'd take part
This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016)
Chicago, Illinoisstudy coordinator listed
Recruiting
Boston Children's Hospital (Site #: 71001)
Boston, Massachusettsstudy coordinator listed
Recruiting
British Columbia Children's Hospital (Site #: 71034)
Vancouver, British Columbia, Canadastudy coordinator listed
Recruiting
Cedars-Sinai Medical Center (Site #: 71026)
Los Angeles, Californiastudy coordinator listed
Recruiting
Children's Hospital of Colorado (Site #: 71019)
Aurora, Coloradostudy coordinator listed
Recruiting
Children's Hospital of Los Angeles (Site #: 71036)
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
Children's Hospital of Philadelphia (Site #: 71091)
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Children's National Medical Center (Site #: 71039)
Washington D.C., District of Columbiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- David Briscoe, MD · STUDY_CHAIR · Boston Children's Hospital: Pediatric Transplantation
- Eileen Chambers, MD · STUDY_CHAIR · Duke University Medical Center: Department of Pediatrics
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of de novo Donor Specific Antibody (dnDSA) (central lab) OR decline in estimated glomerular filtration rate (eGFR) >7.5 mL/min/1.73m^2 (central lab)At 96 weeks post-transplant