NCT00183248View on ClinicalTrials.gov

Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Kidney TransplantationKidney DiseaseKidney Failure
Interventions
DRUG

Alemtuzumab

Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4

DRUG

Mycophenolate mofetil

Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study

DRUG

Sirolimus

Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or end of the study

DRUG

Tacrolimus

Immunosuppressant; daily dose starting Day 1 until withdrawal or end of the study

PROCEDURE

Donor bone marrow stem cell infusion

2 doses of kidney donor's bone marrow stem cells by IV infusion on Day 5 and sometime between Months 4 and 6

PROCEDURE

Kidney transplant

Occurs at study entry

Trial Locations (1)

33136

University of Miami, Miami

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

lead

University of Miami

OTHER

NCT00183248 - Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients | Biotech Hunter | Biotech Hunter