Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
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|ClinicalTrials.gov Identifier: NCT01567085|
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
|Condition or disease||Intervention/treatment||Phase|
|Stage V Chronic Kidney Disease||Drug: Eculizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Sensitized Recipients of a Kidney Transplant From a Deceased Donor.|
|Actual Study Start Date :||August 29, 2012|
|Actual Primary Completion Date :||June 11, 2015|
|Actual Study Completion Date :||May 24, 2017|
Eculizumab 1200 milligrams (mg) was administered intravenously (IV) over 25 to 45 minutes 1 hour prior to kidney allograft reperfusion.
Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days.
Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Other Name: Soliris
- Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation [ Time Frame: Baseline, Week 9 ]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.
- Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 [ Time Frame: Baseline, 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.
- Participants That Developed Severe ACR (Other AE Of Interest) At Month 12 [ Time Frame: Baseline, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567085
|Adelaide, Australia, 5000|
|Camperdown, Australia, 2050|
|Parkville, Australia, 3050|
|Bordeaux, France, 33076|
|Paris, France, 75010|
|Paris, France, 75743|
|Toulouse, France, 31059|
|Tours, France, 37044|
|Brescia, Italy, 25123|
|Padova, Italy, 35128|
|Barcelona, Spain, 08907|
|Gothenburg, Sweden, 413 45|
|Uppsala, Sweden, 751 85|
|Cambridge, United Kingdom, CB2 2QQ|
|London, United Kingdom, SE1 9RT|