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 Details — Status: Completed

Administrative data

• NCT number: NCT02032095
• Other study ID #: B211-10
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 8, 2014
• Last updated: February 3, 2016
• Start date: November 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Japan Blood Products Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• GB-0998

Locations

Country	Name	City	State
Japan	Japan Blood Products Organization	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Japan Blood Products Organization

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative rate of FCXM-T after the fourth administration of GB-0998		at 4 weeks	Yes