Phase 2
Completed N=80
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Stage V Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01567085 ↗
Enrolled (actual)
80
Serious AEs
87.5%
Results posted
May 2019
Primary outcomePrimary: Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation — 7; 73; 3; 4 Participants — p=< 0.001
Summary
Primary Objective:
To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation |
7; 73; 3; 4; 1; 1 | < 0.001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01567085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.