Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
Kidney Failure, Chronic, Kidney Transplantation, Immunosuppression
About this trial
This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring End stage renal disease, Kidney transplantation, Renal transplantation, Kidney failure, Pediatric renal transplant recipients, Alemtuzumab, Campath, Mycophenolate mofetil, MMF, CellCept, Tacrolimus, Prograf, Sirolimus, Rapamycin
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
Sites / Locations
- University of California, San Francisco
- Children's Hospital, Boston
- Children's Hospital, Philadelphia
- Children's Hospital and Regional Medical Center, Seattle
Arms of the Study
Arm 1
Experimental
Alemtuzumab (Campath)
In this open-label, single-arm trial , participants will be administered a 0.3 mg/kg dose of alemtuzumab (Campath) intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants will then receive a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.