Phase 2
Completed N=35
Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
Kidney Failure, Chronic · Chronic Kidney Disease · Immunosuppression
Source: ClinicalTrials.gov NCT00240994 ↗
Enrolled (actual)
35
Serious AEs
71.4%
Results posted
Oct 2012
Primary outcomePrimary: The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation — 0.057 Proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation |
0.057 | — |
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
Data sourced from ClinicalTrials.gov (NCT00240994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.