Status:
COMPLETED
Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Cooperative Clinical Trials in Pediatric Transplantation
Conditions:
Kidney Failure, Chronic
Kidney Transplantation
Eligibility:
All Genders
1-20 years
Phase:
PHASE2
Brief 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 chron...
Detailed Description
Kidney transplantation is widely considered to be the treatment of choice for children with End Stage Renal Disease (ESRD). Improvements in surgical techniques, donor selection, and immunosuppression ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00240994
Start Date
January 1 2005
End Date
November 1 2009
Last Update
January 2 2017
Active Locations (4)
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1
University of California, San Francisco
San Francisco, California, United States, 94143-0116
2
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
3
Children's Hospital, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Children's Hospital and Regional Medical Center, Seattle
Seattle, Washington, United States, 98105