Clinical trial NCT01756508: Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury
Official title: Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End-Stage Renal Disease
Kidney Failure
Graft Reperfusion Injury
Keywords: eculizumab
kidney transplantation
reperfusion
rejection
infection
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2012-12-27
Enrollment: 57
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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) -

Primary outcomes:
measure: speed of the graft warming
timeFrame: at the time of engraftment
Secondary outcomes:
measure: graft morphology changes
timeFrame: one year after transplantation
measure: One-year graft and patient survival, as well as rejection and infection rates will be calculated
timeFrame: one year after Tx
measure: primary graft function
timeFrame: first week after Tx
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Scientfic Center of Surgery
Study officials:
affiliation: Russian Scientific Center of Surgery
name: Michael M Kaabak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Vries DK, van der Pol P, van Anken GE, van Gijlswijk DJ, Damman J, Lindeman JH, Reinders ME, Schaapherder AF, Kooten Cv. Acute but transient release of terminal complement complex after reperfusion in clinical kidney transplantation. Transplantation. 2013 Mar 27;95(6):816-20. doi: 10.1097/TP.0b013e31827e31c9.
citation: Kaabak M, Babenko N, Shapiro R, Zokoyev A, Dymova O, Kim E. A prospective randomized, controlled trial of eculizumab to prevent ischemia-reperfusion injury in pediatric kidney transplantation. Pediatr Transplant. 2018 Mar;22(2). doi: 10.1111/petr.13129. Epub 2018 Jan 29.