The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
NCT ID: NCT02032095
Last Updated: 2016-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
17 participants
INTERVENTIONAL
2013-11-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GB-0998
GB-0998
Interventions
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GB-0998
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
ALL
No
Sponsors
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Japan Blood Products Organization
INDUSTRY
Responsible Party
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Locations
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Japan Blood Products Organization
Tokyo, , Japan
Countries
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Other Identifiers
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B211-10
Identifier Type: -
Identifier Source: org_study_id
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