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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Blood Products Organization
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Patients with stage 4 or 5 on the CKD classification.

• Of the patients that wants a living-donor kidney transplant of ABO blood type compatible, patients with positive FCXM-T and negative CDC-T to the donor.

• Patients with positive FCXM-T after performing twice DFPP therapy

Exclusion Criteria:

• Patients who had taking to continue immunosuppressive drugs or steroids within 4 weeks before obtaining informed consent.

• Patients who had IVIG therapy, or plasmapheresis therapy within 12 weeks before to informed consent.

• Patients who had Rituximab within 6 month before to informed consent.

• Patients who have undergone splenectomy.

• Patients with severe hepatic disorder or severe heart disorder.

• Patients with receiving treatment of malignancy.

• Patients with high risk of thromboembolism.

• Patients with history of shock or hypersensitivity to GB-0998.

• Patients with hereditary fructose intolerance or IgA deficiency.

• Patients with pregnant or probably pregnant.