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

Alexion Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Delayed Graft Function

Treatments: Drug: Eculizumab; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02145182

ECU-DGF-201

2013-004650-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Eculizumab was administered by intravenous (IV) infusion over 25-45 minutes (min) for 2 doses (on the day of transplant then 18-24 hours \[h\] later).

Treatment:

Drug: Eculizumab

Placebo

Placebo Comparator group

Description:

Placebo was administered by IV infusion over 25-45 min for 2 doses (on the day of transplant then 18-24 h later).

Treatment:

Drug: Placebo