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

NCT00183248 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2012-10-02

Study results available
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Summary

Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health.

Conditions

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

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • University of Miami

    lead OTHER

Principal Investigators

  • George W. Burke, III, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00183248 on ClinicalTrials.gov