Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • 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
    • Scottsdale/Phoenix, Arizona: 14-003801
    NCT ID: NCT02145182
    Sponsor Protocol Number: ECU-DGF-201

About this study

The purpose of this study is to determine if Eculizumab is safe and could be used to prevent delayed graft function following kidney transplantation.

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:

  • Subject male or female, 18 years or older
  • Subject with dialysis dependent renal failure (initiated more than 2 months prior to transplant)
  • Subject is to receive a first kidney transplant from a SCD or ECD deceased donor with a DGF risk score using the Irish scale of ≥ 25% (to be determined prior to surgery and before randomization)
  • Subject able to provide written informed consent
  • Subject must be willing and able to comply with the requirements of the study protocol
  • Female subjects of child-bearing potential must have a negative serum pregnancy test (serum beta-hCG) and must be practicing an effective, reliable, and medically approved contraceptive regimen at the time of consent and for up to 5 months following discontinuation of treatment

Exclusion Criteria:

  • Subject to receive a multi-organ transplant
  • Subject to receive kidney(s) from donors < 6 years of age
  • Subject to receive a dual kidney transplant (from same donor, including en bloc)
  • Subject to receive a living donor kidney
  • Subject is highly sensitized (high risk to develop acute AMR) to the donor (as determined by local center practice). Testing to determine high risk may include but is not limited to Flow cytometric cross match, single antigen bead testing and/or complement dependent cytotoxicity
  • Subject has received a previous transplant
  • Subject is participating in another investigational study
  • Subject has a body mass index (BMI) >40 kg/m2 at screening
  • Subject will be the recipient of an A, B, O Blood Glycoproteins (ABO)(blood type) incompatible kidney (A2 donors to B and O recipients will be allowed if the site has the ability to confirm A2 subtype)
  • Subject will receive a kidney from a donation after cardiac death (DCD) donor
  • Subject has a predicted Irish model risk of DGF < 25%
  • Female subjects who are pregnant or breast feeding
  • Female subjects of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
  • Subjects with a history of human immunodeficiency virus (HIV), or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection
  • Subjects with active bacterial or other infection which is clinically significant in the opinion of the Investigator
  • Subjects with a history of splenectomy
  • Subjects with unresolved meningococcal disease
  • Subjects with an unresolved systemic bacterial or fungal infection
  • Subjects with known or suspected hereditary complement deficiency (for example, but not limited to: aHUS, PNH)
  • Subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix that has been treated appropriately
  • Subject has a history of or is believed by the Investigator to have used an illicit drug(s) and/or abused alcohol within 3 months prior to screening
  • Subject has a psychiatric or physical illness that in the opinion of the Investigator would interfere with the ability of the subject to participate in the study

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hasan Khamash, M.D.

Closed for enrollment

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CLS-20143164

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