Desensitization in Kidney Transplantation

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine if deletional strategies will provide effective desensitization.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

Inclusion Criteria:

• Age between 18 and 65

• Voluntary written informed consent

• Patient on deceased donor wait list with a current or peak cytotoxic or calculated panel reactive antibody (PRA) > 20%

Exclusion Criteria:

• Myocardial infarction within 6 months

• Patient received investigational drug within 14 days prior to initiation of study treatment

• Serious medical or psychological illness

• Diagnosed with malignancy within three years, except complete research of basal cell carcinoma or squamous cell carcinoma of skin, an insitu malignancy or low risk prostate cancer after curative therapy

• Absolute neutrophil count (ANC) < 1000

• Receipt of live vaccine within 4 weeks of study entry

• Female subject that is breast feeding