| Trial ID: | L0768 |
| Source ID: | NCT01567085
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| Associated Drug: |
Eculizumab
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| Title: |
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01567085/results
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| Conditions: |
Stage V Chronic Kidney Disease
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| Interventions: |
DRUG: Eculizumab
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| Outcome Measures: |
Primary: Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation, Results are reported for post-transplantation treatment failure and composite endpoints, defined as the occurrence of biopsy-proven acute antibody-mediated rejection (AMR), graft loss, death, or loss to follow-up (including discontinuation) in the first 9 weeks post transplantation. The diagnosis of acute AMR (occurring within the first 9 weeks post transplantation) was based on kidney allograft dysfunction and a biopsy performed due to suspected rejection, proteinuria, increased serum creatinine, or acute tubular necrosis. Treatment failure was the occurrence of at least 1 of the composite endpoint components by Week 9 post transplantation. A participant experiencing multiple events was only counted once for the composite endpoint., Baseline, Week 9 | Other: Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12, Specific analyses of other AEs of interest that occurred at Month 12 included cumulative incidence of clinically significant infection (CSI); post-transplant lymphoproliferative disease (PTLD); malignancies; biopsy-proven acute cellular rejection (ACR) of any grade meeting Banff 2007 criteria; allograft loss for reasons other than AMR. CSIs were defined as infections (confirmed by culture, biopsy, genomic, or serologic findings) that required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator. CSI subcategories of interest included cytomegalovirus (CMV) disease; BK virus disease; encapsulated bacterial infection; fungal infections; aspergillus infections. Results are reported as CIF, where a larger CIF indicates a higher incidence of an AE, and were calculated using Statistical Analysis System software and macro CIF. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module., Baseline, Month 12|Participants That Developed Severe ACR (Other AE Of Interest) At Month 12, This outcome measure focuses on the other AE of interest, severe ACR, which occurred at Month 12. It pertains specifically to the number of participants who developed severe ACR that did not respond to thymoglobulin or other lymphocyte-depleting agents. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module., Baseline, Month 12
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| Sponsor/Collaborators: |
Sponsor: Alexion Pharmaceuticals, Inc.
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
80
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2012-08-29
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| Completion Date: |
2017-05-24
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| Results First Posted: |
2019-05-03
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| Last Update Posted: |
2019-05-03
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| Locations: |
Adelaide, 5000, Australia|Camperdown, 2050, Australia|Parkville, 3050, Australia|Bordeaux, 33076, France|Paris, 75010, France|Paris, 75743, France|Toulouse, 31059, France|Tours, 37044, France|Brescia, 25123, Italy|Padova, 35128, Italy|Barcelona, 08907, Spain|Gothenburg, 413 45, Sweden|Uppsala, 751 85, Sweden|Cambridge, CB2 2QQ, United Kingdom|London, SE1 9RT, United Kingdom
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| URL: |
https://clinicaltrials.gov/show/NCT01567085
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