Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
Condition: Kidney Failure, Chronic; Kidney Transplantation; Immunosuppression
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of alemtuzumab after kidney
      transplantation as part of a multitherapy regimen to prevent kidney graft loss and death and
      to avoid steroids and chronic use of calcineurin inhibitors in pediatric renal transplant
      recipients 1 to 20 years of age.
    

Detailed description: 
      Kidney transplantation is widely considered to be the treatment of choice for children with
      End Stage Renal Disease (ESRD). Improvements in surgical techniques, donor selection, and
      immunosuppression practices, as well as the enhanced experience of specialized pediatric
      transplant teams, have all led to marked improvements in patient and kidney graft survival in
      infants and young children ages 1 to 10. However, young children now have more infections
      following transplant previously. Also, improved graft survival is not observed in pediatric
      renal transplant recipients 11 to 17 years of age. Some studies do indicate that the poor
      long term outcome of patient and kidney survival observed in this age group may be caused by
      noncompliance with immunosuppressive medications. Therefore, protocols that minimize the use
      of immunosuppressive medications while retaining kidney function are necessary for improving
      graft and patient survival in children. This study will evaluate the safety of a regimen
      containing alemtuzumab after kidney transplantation, followed by steroid avoidance and
      calcineurin inhibitor withdrawal in pediatric renal transplant recipients 1 to 20 years of
      age.

      The accrual period is scheduled for 18 months. The study follow-up period will last 24
      months. All participants enrolled will undergo this treatment schedule: 1.) All participants
      will receive intravenous alemtuzumab one day before transplantation and 1 day after
      transplantation. 2.) Mycophenolate mofetil (MMF) will be administered orally no later than 2
      days after transplantation. 3.) Participants will begin to take oral tacrolimus twice a day 1
      to 3 days after transplantation until Weeks 8 through 12 when 4.) Sirolimus will be
      initiated. 5.) Sirolimus and MMF will be taken orally until Month 24.

      Blood collection will occur at baseline, 1 day before transplant, at Days 1 and 3, at Weeks
      2, 4, 6, 8, 10, and at Months 3 through 24. Scheduled kidney (renal) biopsies will be
      performed at transplant, during Weeks 8 through 12, immediately before conversion to
      sirolimus, and at Months 6 and 24.
    

Intervention name(s): Alemtuzumab; Tacrolimus; Mycophenolate mofetil; Sirolimus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered intravenously over a period of 2-3 hours. Two doses total, the first will be one day before transplant and the second will be on the day following transplantation. Pre-medication with methylprednisolone, acetaminophen, and Benadryl will be administered before each dose.; Administered orally at a dose of 0.05-0.1 mg/kg twice daily, beginning 1-3 days following transplantation and continuing until weeks 8-12. Tacrolimus will be discontinued and a treatment regimen with sirolimus will be initiated between weeks 8-12 but some overlap with these medications is possible.; Per recommendation; Administered by either liquid or tablet every 12 hours from month 6 until month 24. Dosage will vary throughout the treatment course.
Other intervention name(s): Campath; Campath- 1H; Prograf; CellCept; Rapamycin
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Alemtuzumab; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: End stage renal disease; Kidney transplantation; Renal transplantation; Kidney failure; Pediatric renal transplant recipients; Alemtuzumab; Campath; Mycophenolate mofetil; MMF; CellCept; Tacrolimus; Prograf; Sirolimus; Rapamycin