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:
Alexion Pharmaceuticals
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
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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:
MedlinePlus related topics:
Kidney Transplantation
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:
- Male or female patients ≥18 years old
- 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
- Able to understand the informed consent form and willing to comply with study procedures
Exclusion Criteria:
- Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
- 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
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Contacts
| Contact: Mary Garfield | 203-271-6481 | Transplant@alxn.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Not yet recruiting | |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Arizona | |
| Recruiting | |
| Tucson, Arizona, United States, 85724 | |
| Contact: Alexion Pharmaceuticals | |
| United States, California | |
| Not yet recruiting | |
| La Jolla, California, United States, 92037 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Los Angeles, California, United States, 90095 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| San Diego, California, United States, 92123 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| San Francisco, California, United States, 94143 | |
| Contact: Alexion Pharmaceuticals | |
| United States, District of Columbia | |
| Recruiting | |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Georgia | |
| Recruiting | |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Illinois | |
| Recruiting | |
| Chicago, Illinois, United States, 60612 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Louisiana | |
| Recruiting | |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Alexion Pharmaceuticals Inc. | |
| United States, Michigan | |
| Recruiting | |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Minnesota | |
| Recruiting | |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Missouri | |
| Recruiting | |
| St Louis, Missouri, United States, 63110 | |
| Contact: Alexion Pharmaceuticals | |
| United States, New Jersey | |
| Recruiting | |
| Livingston, New Jersey, United States, 07039 | |
| Contact: Alexion Pharmaceuticals | |
| United States, New York | |
| Recruiting | |
| New York, New York, United States, 10032 | |
| Contact: Alexion Pharmaceuticals | |
| United States, North Carolina | |
| Recruiting | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Ohio | |
| Recruiting | |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Oklahoma | |
| Recruiting | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Pennsylvania | |
| Recruiting | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Alexion Pharmaceuticals | |
| United States, Texas | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
| Contact: Alexion Pharmaceuticals | |
| Australia, South Australia | |
| Recruiting | |
| North Terrace, South Australia, Australia, 5000 | |
| Contact: Alexion Pharmaceuticals | |
| Australia | |
| Recruiting | |
| Camperdown, Australia, 2050 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Clayton VIC, Australia, 3168 | |
| Contact: Alexion Pharmaceuticals | |
| Not yet recruiting | |
| Parkville VIC, Australia, 3050 | |
| Contact: Alexion Pharmaceuticals | |
| France | |
| Recruiting | |
| Paris, France, 75743 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Paris, France, 75010 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Toulouse Cedex, France, 31059 | |
| Contact: Alexion Pharmaceuticals Inc. | |
| Recruiting | |
| Tours Cedex, France, 37044 | |
| Contact: Alexion Pharmaceuticals | |
| Germany | |
| Not yet recruiting | |
| Dresden, Germany, 01307 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Heidelberg, Germany, 69120 | |
| Contact: Alexion Pharmaceuticals | |
| Italy | |
| Recruiting | |
| Milan, Italy, 20162 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Padova, Italy, 35128 | |
| Contact: Alexion Pharmaceuticals | |
| Netherlands | |
| Recruiting | |
| Rotterdam, Netherlands, 3015 CE | |
| Contact: Alexion Pharmaceuticals | |
| Norway | |
| Recruiting | |
| Oslo, Norway, N-0027 | |
| Contact: Alexion Pharmaceuticals | |
| Spain | |
| Recruiting | |
| Barcelona, Spain, 8036 | |
| Contact: Alexion Pharmaceuticals Inc. | |
| Sweden | |
| Recruiting | |
| Huddinge, Sweden, SE 141 86 | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Uppsala, Sweden, S 751 85 | |
| Contact: Alexion Pharmaceuticals | |
| United Kingdom | |
| Recruiting | |
| London, England, United Kingdom, SE1 9RT | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| London, England, United Kingdom, W12 0HS | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Oxford, England, United Kingdom, OX3 7LJ | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Birmingham, United Kingdom, B15 2TH | |
| Contact: Alexion Pharmaceuticals Inc. | |
| Recruiting | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Contact: Alexion Pharmaceuticals | |
| Recruiting | |
| Coventry, United Kingdom, CV2 2DX | |
| Contact: Alexion Pharmaceuticals | |
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 16, 2013