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

Overview

  • Study type

    Interventional
  • Study phase

    I/II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 09-003392
    NCT ID: NCT01095887
    Sponsor Protocol Number: 09-003392

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Closed for enrollment

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

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