Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Cooperative Clinical Trials in Pediatric Transplantation
• Treatments: Alemtuzumab; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

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