CompletedPhase 2

Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

Australia, France80 participantsStarted 2012-08-29

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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):

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.

What they're measuring

Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation

Timeframe: Baseline, Week 9

Trial details

NCT IDNCT01567085

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06-11

Results submitted2018-05-25

View on ClinicalTrials.gov More Stage V Chronic Kidney Disease trials