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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Delayed Graft Function

In brief

The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.

Key facts

Study ID

NCT02145182

Run by

Alexion Pharmaceuticals, Inc.

People needed

288

Starts

2014-08-21

Expected to finish

2016-11-22

Last updated by the study team

2018-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 years or older
• Has dialysis-dependent renal failure (initiated more than 2 months prior to transplant)
• Participant is to receive a first kidney transplant from a standard criteria donor or expanded criteria donor deceased donor with a DGF risk score using the Irish scale of ≥25% (to be determined prior to surgery and before randomization)
• Able to provide written informed consent
• Willing and able to comply with the requirements of the study protocol
• Female participants of child-bearing potential must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin) 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

You may not qualify if…

• Participant to receive a multi-organ transplant
• Participant to receive kidney(s) from donors <6 years of age
• Participant to receive a dual kidney transplant (from same donor, including en bloc)
• Participant to receive a living donor kidney
• Participant is highly sensitized (high risk to develop acute antibody-mediated rejection) 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
• Participant has received a previous transplant
• Participant is participating in another investigational study
• Participant has a body mass index >40 kilograms/square meter at screening
• Participant 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)
• Participant will receive a kidney from a donation after cardiac death donor
• Participant has a predicted Irish model risk of DGF <25%
• Female participants who are pregnant or breast feeding
• Female participants of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
• Participants with a history of human immunodeficiency virus, or active hepatitis C virus or hepatitis B virus infection
• Participants with active bacterial or other infection which is clinically significant in the opinion of the Investigator
• Participants with a history of splenectomy
• Participants with unresolved meningococcal disease
• Participants with an unresolved systemic bacterial or fungal infection
• Participants with known or suspected hereditary complement deficiency (for example, but not limited to: atypical hemolytic uremic syndrome, paroxysmal nocturnal hemoglobinuria)
• Participant 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
• Participant 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
• Participant has a psychiatric or physical illness that in the opinion of the Investigator would interfere with the ability of the participant to participate in the study

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Francisco, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Livingston, New Jersey, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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