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

J

Japan Blood Products Organization

Status and phase

Completed
Phase 3
Phase 2

Conditions

End Stage Renal Disease

Treatments

Drug: GB-0998

Study type

Interventional

Funder types

Industry

Identifiers

NCT02032095
B211-10

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

GB-0998
Experimental group
Treatment:
Drug: GB-0998

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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