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

February 3, 2016 updated by: Japan Blood Products Organization
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Japan Blood Products Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GB-0998
Drug: GB-0998
Other Names:
  • Intravenous immunoglobulin (Venoglobulin IH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Negative rate of FCXM-T after the fourth administration of GB-0998
Time Frame: at 4 weeks
at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Blood Products Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 3, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B211-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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