CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Alemtuzumab +3 moredrug
Likely dose
Alemtuzumab 2 doses intravenously (days -1 and +1 post-transplant); Tacrolimus 0.05-0.1 mg/kg orally twice daily weeks 1-8-12; Sirolimus every 12 hours months 6-24; Mycophenolate mofetil per recommendationAI-extracted
Key inclusion· 6
  • ✓Age 1 to 20 years (before 21st birthday)
  • ✓End Stage Renal Disease requiring first kidney transplant
  • ✓Living kidney donor identified with no HLA identity mismatch
  • ✓No known contraindications to alemtuzumab therapy
Key exclusion· 11
  • ✕Deceased donor kidney transplant
  • ✕Multiorgan transplant or prior organ transplantation
  • ✕Panel Reactive Antibody (PRA) > 0% within 4 weeks before enrollment
  • ✕History of primary focal segmented glomerulosclerosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00240994
NCT00240994Phase 2Completed
CompareCT.gov

A Phase II Exploratory Study to Determine the Safety and Study the Immunomodulatory Functions of Induction Therapy With Campath, Combined With Chronic Immunosuppression With Mycophenolate Mofetil and Sirolimus

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 18, 2005·Updated Jan 2, 2017

In Brief

A Phase 2 clinical trial evaluating Alemtuzumab, Tacrolimus, and 2 other interventions for Kidney Failure, Chronic and 2 related conditions. Completed, enrolled 35 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Failure, Chronic, Kidney Transplantation, Immunosuppression
CountriesUnited States
CollaboratorsCooperative Clinical Trials in Pediatric Transplantation

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2005
Enrollment StartJan 1, 2005
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.7 years ago

Interventions

Alemtuzumabdrug

Administered intravenously over a period of 2-3 hours. Two doses total, the first will be one day before transplant and the second will be on the day following transplantation. Pre-medication with methylprednisolone, acetaminophen, and Benadryl will be administered before each dose.

Tacrolimusdrug

Administered orally at a dose of 0.05-0.1 mg/kg twice daily, beginning 1-3 days following transplantation and continuing until weeks 8-12. Tacrolimus will be discontinued and a treatment regimen with sirolimus will be initiated between weeks 8-12 but some overlap with these medications is possible.

Mycophenolate mofetildrug

Per recommendation

Sirolimusdrug

Administered by either liquid or tablet every 12 hours from month 6 until month 24. Dosage will vary throughout the treatment course.