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
Intervention: Alemtuzumab; Tacrolimus; Mycophenolate mofetil; Sirolimus
Intervention description: 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.
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Alemtuzumab; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 1 Year
Maximum age: 20 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 1 to 20 (prior to 21st birthday)

          -  End Stage Renal Disease

          -  Necessity of kidney transplant

          -  First kidney transplant received from a living donor

          -  A living kidney donor identified

          -  No known contraindications to therapy with alemtuzumab

          -  Negative pregnancy test before study entry

          -  Willing to use approved methods of contraception for the duration of the study, 6
             weeks after discontinuation of MMF, and 12 weeks after discontinuation of sirolimus

          -  Informed consent from participant, parent, or guardian

          -  Current vaccinations, including varicella-zoster (VZV) vaccine, before study
             enrollment

        Exclusion Criteria:

          -  Recipient of a deceased donor kidney transplant

          -  Multiorgan transplant

          -  History of prior organ transplantation

          -  Participant sensitized to greater than 0% Panel Reactive Antibody (PRA) within 4 weeks
             before study enrollment. (If participant receives a blood transfusion status post PRA
             test, then the PRA must be repeated within 1 week of transplantation)

          -  Participants with human leukocyte antigen (HLA) identical living related donors

          -  History of primary focal segmented glomerulosclerosis

          -  History of other disorders requiring continuous maintenance steroids or calcineurin
             inhibitors

          -  Active systemic infection at time of transplant

          -  History of malignancy

          -  Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or
             hepatitis C virus (HCV)

          -  Contraindication to receive tacrolimus, sirolimus, MMF, or monoclonal antibody therapy

          -  Use of investigational drugs within 4 weeks before study enrollment

          -  Recipient of any licensed or investigational live attenuated vaccine(s) within 2
             months before study enrollment

          -  Family history of high cholesterol