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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
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:

Primary Objective:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab

Arm Intervention/treatment
Experimental: Eculizumab

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.

Drug: Eculizumab
Other Name: Soliris




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female participants ≥18 years old.
  2. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
  3. History of prior exposure to HLA (human leukocyte antigen):

    • Prior solid organ or tissue allograft
    • Pregnancy
    • Blood transfusion
    • Prior exposure to specific donor's HLA

Exclusion Criteria:

  1. Has received treatment with eculizumab at any time prior to enrolling in this study.
  2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
  3. History of severe cardiac disease.
  4. Prior splenectomy.

Information from the National Library of Medicine

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


Locations
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Australia
Adelaide, Australia, 5000
Camperdown, Australia, 2050
Parkville, Australia, 3050
France
Bordeaux, France, 33076
Paris, France, 75010
Paris, France, 75743
Toulouse, France, 31059
Tours, France, 37044
Italy
Brescia, Italy, 25123
Padova, Italy, 35128
Spain
Barcelona, Spain, 08907
Sweden
Gothenburg, Sweden, 413 45
Uppsala, Sweden, 751 85
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Alexion Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Alexion Pharmaceuticals:
Study Protocol  [PDF] October 8, 2013
Statistical Analysis Plan  [PDF] November 12, 2013


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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01567085     History of Changes
Other Study ID Numbers: C10-002
2010-019631-35 ( EudraCT Number )
First Posted: March 30, 2012    Key Record Dates
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency