End Stage Renal Disease
Conditions
Keywords
IVIG, Renal transplantation, desensitization
Brief 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.
Interventions
DRUGGB-0998
Sponsors
Japan Blood Products Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative rate of FCXM-T after the fourth administration of GB-0998 | at 4 weeks |
Countries
Japan
Outcome results
None listed