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

Completed · Phase 2

Conditions studied: Kidney Failure, Chronic, Kidney Transplantation, Immunosuppression

In brief

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.

Key facts

Study ID

NCT00240994

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

35

Starts

2005-01-01

Expected to finish

2009-11-01

Last updated by the study team

2017-01-02

Who can join

Age: 1 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Children's Hospital, Boston — Boston, Massachusetts, United States
• Children's Hospital, Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital and Regional Medical Center, Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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