End-Stage Renal Disease, Graft Reperfusion Injury, Kidney Failure
Conditions
Keywords
eculizumab, kidney transplantation, reperfusion, rejection, infection
Brief summary
Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.
Detailed description
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.
Interventions
DRUGeculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
Sponsors
Russian Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 80 Years
Healthy volunteers
No
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) -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| speed of the graft warming | at the time of engraftment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| graft morphology changes | one year after transplantation | Protocol biopsy will be obtained at one month and one year. Progression of allograft nephropathy will be compared between groups. |
| One-year graft and patient survival, as well as rejection and infection rates will be calculated | one year after Tx | — |
| primary graft function | first week after Tx | 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; |
Countries
Russia
Outcome results
None listed