Phase 2 N=80 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT01567085 ↗

Enrolled (actual)

Serious AEs

87.5%

Results posted

May 2019

Primary outcome: Primary: Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation — 7; 73; 3; 4 Participants — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Eculizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alexion Pharmaceuticals, Inc.
Primary completion: Jun 2015

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

Summary

Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

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.

View full record on ClinicalTrials.gov →

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.