Advancing Transplantation Outcomes in Children

Conditions

• Kidney Transplant

Eligibility Criteria

Sex

ALL

Age

13 Years - 20 Years

Healthy Volunteers

Not accepted

Interventions

• Sirolimus — DRUG
  Participants in Group 1 will transition to sirolimus therapy on day 14 (+/- 5 days) - weight \<40 kg will receive 3mg/m\^ 2, with maintenance dose of 1 mg/m\^2 divided BID - weight \>= 40kg will receive 6mg/m\^ 2, with maintenance dose of 2 mg daily
• Belatacept — BIOLOGICAL
  Belatacept will be administered as an intravenous infusion over 30 minutes. The belatacept dose for the study is 10 mg/kg on post-operative day (POD) 1, 5, 14, 28, 56, 84 for the first 3 months, followed by 5 mg/kg every 4 weeks (+/-4 days), starting on month 4 until month 24
• Mycophenolate Mofetil — DRUG
  Mycophenolate Mofetil-MMF will be initiated at 600 mg/m\^2 BID until tacrolimus is at therapeutic levels, then 450 mg/m\^2 BID
• Tacrolimus (Group1) — DRUG
  Participants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels. Participants in Group 1 will be transitioned to sirolimus 2-4 weeks post-transplant
• Anti-Thymocyte Globulin (ATG) — DRUG
  Participants will receive induction therapy with anti-thymocyte globulin (1.5 mg/kg/dose, maximum 125 mg) starting intraoperatively on day 0 and continuing on days 2 and 3 (total dose 4.5 mg/kg). Total dose may be extended to 6 mg/kg over 1-2 days for delayed graft function
• Tacrolimus (Group 2) — DRUG
  Participants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels

Study Details

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.

Key Dates

Start date

May 22, 2024

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: (Group 1): Belatacept+Sirolimus group
  Participants in this group will receive antithymocyte globulin (ATG) + steroid taper + belatacept + (tacrolimus bridge, day 0-14) with conversion to sirolimus (day 30 +/-14 days)
• Active Comparator: (Group 2): Tacrolimus + Mycophenolate Mofetil (MMF) group
  Participants in this group will receive anti-thymocyte globulin (ATG) + steroid taper + tacrolimus + MMF

Primary Outcome Measure

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) [ Time Frame: At 96 weeks post-transplant ]

Locations (20)

Find similar trials in Birmingham, AL

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