Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys

PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

November 30, 1999

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Graft RejectionKidney Disease
Interventions
DRUG

Alemtuzumab and DSG

Alemtuzumab was administered intravenously at 0.3 mg/kg/dose over 3 hr. Patients received one dose on each of days -1,+1,+3 and +5 relative to transplantation (total dose 1.2 mg/kg). Methylprednisolone was given prior to each dose to limit the cytokine release: 500 mg prior to dose 1, 125 mg prior to dose 2, and 60 mg prior to doses 3 and 4. Deoxyspergualin was dosed as follows. The first two patients received 4 mg/kg as a loading dose on the day of transplant and 2.5 mg/kg daily for 13 additional days (14 days of treatment; 36.5 mg/kg total dose). The next three patients received the same dosing regimen but it was initiated on postoperative day 12 to coincide with the resurgence of monocytes on days 12- 25.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT00001984 - Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys | Biotech Hunter | Biotech Hunter