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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567085
First Posted: March 30, 2012
Last Update Posted: September 13, 2017
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.
Information provided by (Responsible Party):
Alexion Pharmaceuticals
  Purpose

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 Intervention Phase
Stage V Chronic Kidney Disease Drug: Eculizumab Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

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

Enrollment: 80
Study Start Date: May 2012
Study Completion Date: May 24, 2017
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01567085     History of Changes
Other Study ID Numbers: C10-002
2010-019631-35 ( EudraCT Number )
First Submitted: March 27, 2012
First Posted: March 30, 2012
Last Update Posted: September 13, 2017
Last Verified: September 2017

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