Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

Russian Academy of Medical Sciences (RAMS)

Status and phase: Completed; Phase 2

Conditions: Kidney Failure; End-Stage Renal Disease; Graft Reperfusion Injury

Treatments: Drug: eculizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01756508

Eculizumab for reperfusion

Details and patient eligibility

About

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

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 12 months to 80 years old

Volunteers: No Healthy Volunteers

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) -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

eculizumab

Experimental group

Description:

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

Treatment:

Drug: eculizumab

control

No Intervention group

Description:

No intervention will be applied instead eculizumab infusion