Chronic kidney disease Kidney Failure, Chronic
Conditions
Interventions
Administer 900 mg of eculizumab by intravenous infusion immediately before reperfusion of the transplanted kidney.
C475108
Eculizumab
Sponsors
Kazunari Tanabe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (18 years or older) who undergo ABO-incompatible living donor kidney transplantation at Shonan Kamakura General Hospital between the jRCT publication date and December 2026, and from whom written informed consent for participation in the study has been obtained.
Exclusion criteria
Exclusion criteria: 1. Patients with pre-existing complement disorders 2. Patients with severe infections 3. Pregnant or breastfeeding women 4. Patients who are unable to receive meningococcal vaccination 5. Patients who have had a severe allergic reaction to eculizumab in the past 6. Other patients deemed unsuitable for study participation by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No acute rejection and no thrombotic microangiopathy (TMA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of ABO incompatible kidney transplantation (including graft function, rejection, and incidence of complications) Immunological evaluation (from the day of transplantation) Presence or absence of donor-specific antibodies(DSA) with mean fluorescence intensity (MFI) below 500 Presence or absence of complement activation (decreased C3, C4 levels, elevated sC5b-9) Clinical evaluation Graft function at 4 weeks post-transplant (serum creatinine, urine output) Presence or absence of acute rejection (antibody mediated rejection) Evaluation of complications Number of cases of thrombotic microangiopathy (TMA), infections, and hemorrhagic complications 1. Changes in renal function (serum creatinine [sCr], estimated glomerular filtration rate [eGFR], urine output, urinary protein, and urinary sediment examination) 2. Graft engraftment (absence of rejection and thrombotic microangiopathy [TMA], immunological stability, and stable blood flow) 3. Changes in complement activity (C3 and C4 complement levels, sC5b-9, CH50, and anti-ABO antibody titers) | — |
Contacts
Public ContactTanabe Kazunari
Shonan Kamakura General Hospital
Outcome results
None listed