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Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation

NCT00642655 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-03-25

No results posted yet for this study

Summary

The purpose of this study is to examine the safety and efficacy of IVIG in combination with Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a transplanted organ in patients who are highly HLA-sensitized and are awaiting transplantation.

Conditions

  • Kidney Transplant

Interventions

DRUG

IVIG and Rituximab

IVIG 2gm/kg given intravenously on day#0 and day#30 Rituximab 1gm given intravenously on day#7 and day#22

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Biogen

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Stanley C. Jordan, MD · Cedars-Sinai Medical Center

  • Ashley A Vo, PharmD · Cedars-Sinai Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00642655 on ClinicalTrials.gov