Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Kidney Failure, ChronicKidney TransplantationImmunosuppression
Interventions
DRUG

Alemtuzumab

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.

DRUG

Tacrolimus

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.

DRUG

Mycophenolate mofetil

Per recommendation

DRUG

Sirolimus

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

Trial Locations (4)

19104

Children's Hospital, Philadelphia, Philadelphia

98105

Children's Hospital and Regional Medical Center, Seattle, Seattle

94143-0116

University of California, San Francisco, San Francisco

02115

Children's Hospital, Boston, Boston

All Listed Sponsors
collaborator

Cooperative Clinical Trials in Pediatric Transplantation

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00240994 - Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients | Biotech Hunter | Biotech Hunter