Back to resultsThe Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
GB-0998
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring IVIG, Renal transplantation, desensitization
Eligibility Criteria
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.
Sites / Locations
- Japan Blood Products Organization
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GB-0998
Arm Description
Outcomes
Primary Outcome Measures
Negative rate of FCXM-T after the fourth administration of GB-0998
Secondary Outcome Measures
Full Information
NCT ID
NCT02032095
First Posted
January 8, 2014
Last Updated
February 3, 2016
Sponsor
Japan Blood Products Organization
1. Study Identification
Unique Protocol Identification Number
NCT02032095
Brief Title
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
Official Title
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Japan Blood Products Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
IVIG, Renal transplantation, desensitization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GB-0998
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GB-0998
Other Intervention Name(s)
Intravenous immunoglobulin (Venoglobulin IH)
Primary Outcome Measure Information:
Title
Negative rate of FCXM-T after the fourth administration of GB-0998
Time Frame
at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Japan Blood Products Organization
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
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