Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01756508
Recruitment Status : Recruiting
First Posted : December 27, 2012
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
Michael Kaabak, Russian Academy of Medical Sciences

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

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Kidney Failure Graft Reperfusion Injury Drug: eculizumab Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation.
Study Start Date : March 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
Drug: eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
Other Name: Soliris
No Intervention: control
No intervention will be applied instead eculizumab infusion

Primary Outcome Measures :
  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.

  2. initial 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;

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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) -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756508

Contact: Michael M Kaabak, professor 8-499-248-13-44
Contact: Victor A Goryainov, doctor 8-926-532-70-04

Russian Federation
Russian Scientfic Center of Surgery Recruiting
Moscow, Russian Federation, 119992
Contact: Michael M Kaabak, MD   
Contact: Victor A Goryainov    926- 532-7004   
Sponsors and Collaborators
Russian Academy of Medical Sciences
Principal Investigator: Michael M Kaabak, MD Russian Scientific Center of Surgery

Responsible Party: Michael Kaabak, professor, Russian Academy of Medical Sciences Identifier: NCT01756508     History of Changes
Other Study ID Numbers: Eculizumab for reperfusion
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

Keywords provided by Michael Kaabak, Russian Academy of Medical Sciences:
kidney transplantation

Additional relevant MeSH terms:
Wounds and Injuries
Kidney Failure, Chronic
Renal Insufficiency
Reperfusion Injury
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes