Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
Study Identifier:
C10-001
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Study Details
Medical Condition
- Antibody Mediated Rejection
Study Drug
- Drug: Eculizumab
Date
Nov 2011 - May 2014
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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
- Exclusion Criteria:
- ABO incompatible with living donor
- 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
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Antibody Mediated Rejection
Study Drug
- Drug: Eculizumab
Date
Nov 2011 - May 2014
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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
- Exclusion Criteria:
- ABO incompatible with living donor
- 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
Protocol Summary
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.
Trial Locations
Location
Status
Location
Birmingham, Alabama, United States, 35294
Status
N/A
Location
La Jolla, California, United States, 92037
Status
N/A
Location
Los Angeles, California, United States, 90095
Status
N/A
Location
San Francisco, California, United States, 94143
Status
N/A
Location
Washington D.C., District of Columbia, United States, 20007
Status
N/A
Location
Atlanta, Georgia, United States, 30309
Status
N/A
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