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

This study is currently recruiting participants.
Verified March 2013 by Alexion Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01399593
First received: July 19, 2011
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Antibody Mediated Rejection
 Drug: Eculizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

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

Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eculizumab
IV administration over 35-45 minutes
 Drug: Eculizumab
IV administered over 35-45 minutes
No Intervention: Standard of Care

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399593

Contacts
Contact: Mary Garfield 203-271-6481 Transplant@alxn.com

  Show 45 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01399593     History of Changes
Other Study ID Numbers: C10-001, 2010-019630-28, BB-IND: 100,003
Study First Received: July 19, 2011
Last Updated: March 8, 2013
Health Authority: United States: Food and Drug Administration
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
Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (MERC)
Norway: Regional Ethics Commitee (REK)
Sweden: Regional Ethical Review Board

Keywords provided by Alexion Pharmaceuticals:
Antibody Mediated Rejection
AMR
Acute Humoral Rejection
 AHR
Living Donor
Kidney Transplant

ClinicalTrials.gov processed this record on May 23, 2013