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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01567085
First received: March 27, 2012
Last updated: September 3, 2014
Last verified: September 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01567085     History of Changes
Other Study ID Numbers: C10-002, 2010-019631-35
Study First Received: March 27, 2012
Last Updated: September 3, 2014
Health Authority: Australia: National Health and Medical Research Council
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014