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

Japan Blood Products Organization

Status and phase

Completed

Phase 3

Phase 2

Conditions

End Stage Renal Disease

Treatments

Drug: GB-0998

Study type

Interventional

Funder types

Industry

Identifiers

NCT02032095

B211-10

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.