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

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ClinicalTrials.gov Identifier: NCT02032095
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Japan Blood Products Organization

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: GB-0998 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
Study Start Date : November 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GB-0998 Drug: GB-0998
Other Name: Intravenous immunoglobulin (Venoglobulin IH)




Primary Outcome Measures :
  1. Negative rate of FCXM-T after the fourth administration of GB-0998 [ Time Frame: at 4 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032095


Locations
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Japan
Japan Blood Products Organization
Tokyo, Japan
Sponsors and Collaborators
Japan Blood Products Organization

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Responsible Party: Japan Blood Products Organization
ClinicalTrials.gov Identifier: NCT02032095     History of Changes
Other Study ID Numbers: B211-10
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Keywords provided by Japan Blood Products Organization:
IVIG
Renal transplantation
desensitization
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Antibodies
Immunologic Factors
Physiological Effects of Drugs