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Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

This study is currently recruiting participants.
Verified April 2016 by Michael Kaabak, Russian Academy of Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756508
First Posted: December 27, 2012
Last Update Posted: April 6, 2016
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.
Information provided by (Responsible Party):
Michael Kaabak, Russian Academy of Medical Sciences
  Purpose
Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.

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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Michael Kaabak, Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.

  • One-year graft and patient survival, as well as rejection and infection rates will be calculated [ Time Frame: one year after Tx ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
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) -
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01756508


Contacts
Contact: Michael M Kaabak, professor 8-499-248-13-44 kaabak@hotmail.com
Contact: Victor A Goryainov, doctor 8-926-532-70-04 vik-kid@mail.ru

Locations
Russian Federation
Russian Scientfic Center of Surgery Recruiting
Moscow, Russian Federation, 119992
Contact: Michael M Kaabak, MD       kaabak@hotmail.com   
Contact: Victor A Goryainov    926- 532-7004    vik-kid@mail.ru   
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
Principal Investigator: Michael M Kaabak, MD Russian Scientific Center of Surgery
  More Information

Publications:
Responsible Party: Michael Kaabak, professor, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01756508     History of Changes
Other Study ID Numbers: Eculizumab for reperfusion
First Submitted: December 20, 2012
First Posted: December 27, 2012
Last Update Posted: April 6, 2016
Last Verified: April 2016

Keywords provided by Michael Kaabak, Russian Academy of Medical Sciences:
eculizumab
kidney transplantation
reperfusion
rejection
infection

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