Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Roche Pharma AG
• Treatments: Immunoglobulins, Intravenous; Rituximab

Criteria

Inclusion Criteria:

• Age ≥ 18

• patients who are on the waiting list more than 4 years

• PRA I or II > 50%

Exclusion Criteria:

• Recent recipients of any live attenuated vaccine(s) within 4 weeks

• Subjects who have received IVIG or B cell depleting agents previously

• Subjects with positive result for viral hepatitis(B,C) or HIV infection

• Subjects with active infection

• Lactating or pregnant females

• Subjects who have history of malignancy in recent 5years

• Subjects who have experience of treatment for the psychiatric problem in recent 6months

• Subjects who have hematologic abnormality (Hb < 7g/dL, Platelet < 100,000/mm3, AST/ALT > 80IU)