Kidney; Complications, Allograft Clinical Trial
Official title:
Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation: A Randomized, Open-Label, Pilot Intervention Trial
This study is designed to assess the effectiveness of eculizumab in recipients of kidney
transplantation with donor-specific antibodies (DSA) and worsening kidney function and to
assess if eculizumab improves endothelial cell injury in the kidney.
The investigators hypothesize that complement inhibition with eculizumab will reduce
allograft injury, resulting from less complement-mediated injury of endothelial cells and
less endothelial cell activation.
This study will address the clinical challenge that currently exists in the management of
kidney transplant recipients who have developed de novo DSA, have deteriorating graft
function, yet have no established treatment alternative.
This is a randomized, open-label, pilot intervention trial. Post transplant patients with
deteriorating renal function (defined as 20% reduction in GFR) will be screened for the
development of DSA and biopsied for the presence of C4d deposition. All patients with DSA and
those meeting inclusion/exclusion criteria will undergo protocol renal biopsy and will be
assessed for C4d deposition. Participants will be randomized to treatment with eculizumab
plus standard of care (SOC) or SOC only. Randomization will be stratified by C4d status
(C4d+/C4d-) with 10 subjects (7 eculizumab, 3 SOC only) in each stratum.
Eculizumab is an antibody that has been developed to inhibit the complement protein C5.
Eculizumab will be delivered via IV according to the following schedule:
- Eculizumab Induction 600mg IV every 7 days for 4 doses
- Eculizumab 900mg IV 7 days later
- Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02036554 -
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|
Phase 4 | |
| Completed |
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|