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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 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

March 27, 2012
September 3, 2014
May 2012
September 2015   (final data collection date for primary outcome measure)
Post-transplantation treatment failure rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01567085 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
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.

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stage V Chronic Kidney Disease
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.

Experimental: Eculizumab
Intervention: Drug: Eculizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
June 2016
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   France,   Italy,   Spain,   Sweden,   United Kingdom
 
NCT01567085
C10-002, 2010-019631-35
Yes
Alexion Pharmaceuticals
Alexion Pharmaceuticals
Not Provided
Not Provided
Alexion Pharmaceuticals
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP