Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury
NCT ID: NCT01756508
Last Updated: 2018-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2012-09-01
2017-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
control
No intervention will be applied instead eculizumab infusion
No interventions assigned to this group
Interventions
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eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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) -
12 Months
80 Years
ALL
No
Sponsors
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Russian Academy of Medical Sciences
OTHER
Responsible Party
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Michael Kaabak
professor
Principal Investigators
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Michael M Kaabak, MD
Role: PRINCIPAL_INVESTIGATOR
Russian Scientific Center of Surgery
Locations
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Russian Scientfic Center of Surgery
Moscow, , Russia
Countries
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References
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de Vries DK, van der Pol P, van Anken GE, van Gijlswijk DJ, Damman J, Lindeman JH, Reinders ME, Schaapherder AF, Kooten Cv. Acute but transient release of terminal complement complex after reperfusion in clinical kidney transplantation. Transplantation. 2013 Mar 27;95(6):816-20. doi: 10.1097/TP.0b013e31827e31c9.
Kaabak M, Babenko N, Shapiro R, Zokoyev A, Dymova O, Kim E. A prospective randomized, controlled trial of eculizumab to prevent ischemia-reperfusion injury in pediatric kidney transplantation. Pediatr Transplant. 2018 Mar;22(2). doi: 10.1111/petr.13129. Epub 2018 Jan 29.
Other Identifiers
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Eculizumab for reperfusion
Identifier Type: -
Identifier Source: org_study_id
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