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The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.

End Stage Renal Disease Clinical Trial

Official title:
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.

Clinical Trial Summary

It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02032095
Study type Interventional
Source Japan Blood Products Organization
Contact
Status Completed
Phase Phase 2/Phase 3
Start date November 2013
Completion date September 2015
View Details
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