Overview

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