Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

Phase 2

Completed

• Conditions: Graft Reperfusion Injury; Kidney Failure; End-Stage Renal Disease
• Interventions: Drug: eculizumab

• Registration Number: NCT01756508
• Lead Sponsor: Russian Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2012-09-01
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-27
• Primary Completion: 2017-04-15
• Study Completion: 2017-12-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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) -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eculizumab	eculizumab	Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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;

Trial Locations

Locations (1)

Russian Scientfic Center of Surgery; 🇷🇺 Moscow, Russian Federation