Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

Russian Academy of Medical Sciences57 enrolled

Overview

Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.

Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It was further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. For testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

End-Stage Renal Disease Kidney Failure Graft Reperfusion Injury

Interventions

eculizumabDRUG

Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age 1-80 2. weight - \>6 kg 3. male or female 4. recipient of first kidney graft either from standard criteria deceased or live donor 5. end stage renal disease or congenital nephrotic syndrome - Exclusion Criteria: 1. Blood group (ABO) incompatible transplantation 2. presence of donor-specific anti-human leukocyte antigen (HLA) antibodies 3. multiorgan transplantation 4. previous transplant 5. patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV) 6. patients with haemolytic-uraemic syndrome (HUS) -

Locations (1)

Russian Scientfic Center of Surgery

Moscow, Russia

Outcomes

Primary Outcomes

speed of the graft warming

The speed of the graft surface warming in the range 15-20°C is accessed on the the infrared video record, taken during graft reperfusion by Nec Thermo Tracer.

Time frame: at the time of engraftment

Secondary Outcomes

graft morphology changes

Protocol biopsy will be obtained at one month and one year. Progression of allograft nephropathy will be compared between groups.

Time frame: one year after transplantation

One-year graft and patient survival, as well as rejection and infection rates will be calculated

Time frame: one year after Tx

primary graft function

initial graft function will be accessed daily during the first week post Tx and measured as follows: * the rate of serum creatinine decrease expressed as percent per day, where 100% will be the creatinine on the day before; * intragraft blood flow by Doppler indexes (acceleration, resistance) and blood flow velocity on the three levels - main, interlobar and arcuate arteries;

Time frame: first week after Tx

Data from ClinicalTrials.gov

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