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Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eculizumab | Experimental | Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion |
|
| control | No Intervention | No intervention will be applied instead eculizumab infusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eculizumab | Drug | Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| speed of the graft warming | 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. | at the time of engraftment |
| Measure | Description | Time Frame |
|---|---|---|
| graft morphology changes | Protocol biopsy will be obtained at one month and one year. Progression of allograft nephropathy will be compared between groups. | one year after transplantation |
| One-year graft and patient survival, as well as rejection and infection rates will be calculated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael M Kaabak, MD | Russian Scientific Center of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian Scientfic Center of Surgery | Moscow | 119992 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23348894 | Background | 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. | |
| 29377474 | Background |
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Individual participant data, except for personal data like Name, Forename, and address, will be shared by request
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| D012059 | Rejection, Psychology |
| D007239 | Infections |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C481642 | eculizumab |
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| one year after Tx |
| primary graft function | initial graft function will be accessed daily during the first week post Tx and measured as follows:
| first week after Tx |
| 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. |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |