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Desensitization in Kidney Transplantation

NCT00908583 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-04-01

Study results available
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Summary

To determine if deletional strategies will provide effective desensitization.

Conditions

  • HLA Sensitization

Interventions

DRUG

plasmapheresis

Patients will receive plasmapheresis 1.5 x plasma volume prior to each Bortezomib dose. Plasma volume replacement will be per physician discretion.

DRUG

Bortezomib

Patients will receive bortezomib as described in protocol

DRUG

Rituximab

Patients will receive rituximab as described in protocol

DRUG

Methylprednisolone

Each bortezomib dose will be preceded by intravenous methylprednisolone (100mg for first two doses and 50mg for following doses).

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • E. Steve Woodle, MD · University of Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00908583 on ClinicalTrials.gov