Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567085
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:

Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent Antibody Mediated Rejection (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)
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.
Study Start Date : May 2012
Primary Completion Date : June 2015
Study Completion Date : May 24, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Eculizumab Drug: Eculizumab

Eculizumab 1200 mg (4 vials) administered intravenously (IV) over 35 to 45 minutes.

Eculizumab 900 mg (3 vials) administered IV over 35 to 45 minutes.

Primary Outcome Measures :
  1. Post-transplantation treatment failure rate [ Time Frame: 12 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Male or female patients ≥ 18 years old
  2. Patients with Stage V chronic kidney disease who will receive a kidney transplant from a deceased donor to whom they are 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. ABO (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 identifier (NCT number): NCT01567085

Camperdown, Australia, 2050
North Terrace, Australia, 5000
Parkville VIC, 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
Upsala, Sweden, 751 85
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Alexion Pharmaceuticals

Responsible Party: Alexion Pharmaceuticals Identifier: NCT01567085     History of Changes
Other Study ID Numbers: C10-002
2010-019631-35 ( EudraCT Number )
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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