| Trial ID: | L1529 |
| Source ID: | NCT01756508
|
| Associated Drug: |
Eculizumab
|
| Title: |
Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-Stage Renal Disease|Kidney Failure|Graft Reperfusion Injury
|
| Interventions: |
DRUG: eculizumab
|
| Outcome Measures: |
Primary: 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 | Secondary: 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, one year after Tx|primary graft function, 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;, first week after Tx
|
| Sponsor/Collaborators: |
Sponsor: Russian Academy of Medical Sciences
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
57
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2012-09-01
|
| Completion Date: |
2017-12-01
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-31
|
| Locations: |
Russian Scientfic Center of Surgery, Moscow, 119992, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT01756508
|
