Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01399593
First received: July 19, 2011
Last updated: September 3, 2014
Last verified: September 2014

July 19, 2011
September 3, 2014
September 2011
March 2015   (final data collection date for primary outcome measure)
The primary composite endpoint is the Week 9 post-transplantation treatment failure rate defined as the occurrence of 1) biopsy-proven AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up. The diagnosis of AMR will be based on kidney allograft [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary analysis of all endpoints will occur after all patients have reached Month 12 post-transplantation.
Same as current
Complete list of historical versions of study NCT01399593 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
A Randomized, Open-label, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Living Donor Kidney Transplant Recipients Requiring Desensitization Therapy

The purpose of this trial is to determine the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Antibody Mediated Rejection
Drug: Eculizumab
IV administered over 35-45 minutes
  • Experimental: Eculizumab
    IV administration over 35-45 minutes
    Intervention: Drug: Eculizumab
  • No Intervention: Standard of Care
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
102
April 2016
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patients ≥18 years old
  2. Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation
  3. Able to understand the informed consent form and willing to comply with study procedures

Exclusion Criteria:

  1. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
  2. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom
 
NCT01399593
C10-001, 2010-019630-28, BB-IND: 100,003
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