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

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: GB-0998

• Registration Number: NCT02032095
• Lead Sponsor: Japan Blood Products Organization

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GB-0998	GB-0998	-

Primary Outcome Measures

Name	Time	Method
Negative rate of FCXM-T after the fourth administration of GB-0998	at 4 weeks

Trial Locations

Locations (1)

Japan Blood Products Organization; 🇯🇵 Tokyo, Japan