Skip to main content
OpenTrials
Completed

NCT Number: NCT01756508

Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End-stage Renal Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft Reperfusion Injury Infections Kidney Diseases Kidney Failure Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rejection, Psychology Renal Insufficiency Renal Insufficiency, Chronic Social Behavior Urogenital Diseases Urologic Diseases

Age range

12 month–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Russian Scientfic Center of Surgery

Moscow, 119992, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 1-80
  • weight - >6 kg
  • male or female
  • recipient of first kidney graft either from standard criteria deceased or live donor
  • end stage renal disease or congenital nephrotic syndrome -

Exclusion criteria

  • Blood group (ABO) incompatible transplantation
  • presence of donor-specific anti-human leukocyte antigen (HLA) antibodies
  • multiorgan transplantation
  • previous transplant
  • patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • patients with haemolytic-uraemic syndrome (HUS) -

Treatment and study plan

Eculizumab

Drug

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

Other names: Soliris

Primary outcomes

  1. speed of the graft warming

    Time frame: 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 outcomes

  1. graft morphology changes

    Time frame: one year after transplantation

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

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

    Time frame: one year after Tx

  3. primary graft function

    Time frame: 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;

Sponsors and collaborators

Lead sponsor

Russian Academy of Medical Sciences

Other

Registry information

Official study title

Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation.

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 27, 2012
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.