A Study of the Safety and Effectiveness of Eculizumab to Prevent Antibody-Mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of  eculizumab for the prevention of antibody-caused rejection in patients who are having a kidney transplant from a living donor with a different blood type than their own.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age at least 18 years
  • Have end stage renal disease (ESRD) and  receiving a kidney transplant from a living donor to whom he/she has a baseline anti-blood group titer >1:32
  • Vaccinated against N. meningitides (quadrivalent vaccine), H. Flu, and pneumococcal disease at least two weeks prior to beginning desensitization

Exclusion Criteria

  • Has an unstable cardiovascular condition
  • Has had a previous splenectomy
  • Has any active bacterial or other infection
  • Has a known or suspected hereditary complement deficiency
  • Has known hypersensitivity to the treatment drug or any of its excipients
  • Has history of illicit drug use or alcohol abuse within the previous year
  • Has history of meningococcal disease
  • Has any medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, pose an added risk for the patient, or confound the assessment of the patient (e.g. severe cardiovascular or pulmonary disease)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314833

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