Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Russian Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Michael Kaabak, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01756508
First received: December 20, 2012
Last updated: April 5, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • speed of the graft warming [ Time Frame: at the time of engraftment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   12 Months to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 20, 2012
Last Updated: April 5, 2013
Health Authority: Russian Federation: Federal Service on Surveillance in Healthcare

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

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

ClinicalTrials.gov processed this record on July 28, 2014