Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation… (NCT00240994) | Clinical Trial Compass
CompletedPhase 2
Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
United States35 participantsStarted 2005-01
Plain-language 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.
Who can participate
Age range1 Year – 20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mo…
What they're measuring
1
The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation
Timeframe: Up to one year post kidney transplantation procedure
Trial details
NCT IDNCT00240994
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)