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

NCT02032095 | Completed Phase 2

• 1 other identifier: B211-10
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

IVIG; Renal transplantation; desensitization

Outcome Measures

Primary Outcomes (1)

• Negative rate of FCXM-T after the fourth administration of GB-0998

  at 4 weeks

Study Arms (1)

GB-0998

EXPERIMENTAL

Drug: GB-0998

Interventions

GB-0998 DRUG

Also known as: Intravenous immunoglobulin (Venoglobulin IH)

GB-0998

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Japan Blood Products Organization: lead

Study Sites (1)

Japan Blood Products Organization

Tokyo, Japan

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: November 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

JP (1)