Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT00240994
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
20 Years
Study:
NCT00240994
Study Brief:
Protocol Section:
NCT00240994