Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Study Identifier:
C10-002
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Eculizumab
Date
Aug 2012 - Jun 2015
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
- Male or female participants ≥18 years old.
- Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
- 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
- Has received treatment with eculizumab at any time prior to enrolling in this study.
- Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
- History of severe cardiac disease.
- Prior splenectomy.
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Eculizumab
Date
Aug 2012 - Jun 2015
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
- Male or female participants ≥18 years old.
- Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
- 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
- Has received treatment with eculizumab at any time prior to enrolling in this study.
- Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
- History of severe cardiac disease.
- Prior splenectomy.
Protocol Summary
Primary Objective:
To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
Trial Locations
Location
Status
Location
Adelaide, Australia, 5000
Status
N/A
Location
Camperdown, Australia, 2050
Status
N/A
Location
Parkville, Australia, 3050
Status
N/A
Location
Bordeaux, France, 33076
Status
N/A
Location
Paris, France, 75010
Status
N/A
Location
Paris, France, 75743
Status
N/A
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