Clinical trial NCT02145182: Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
Official title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Delayed Graft Function
Keywords: DGF
Dialysis
Kidney
Kidney Transplantation
eGFR
Complement
Eculizumab
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
First posted: 2014-05-22
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant
timeFrame: First 7 days post transplantation
Secondary outcomes:
measure: Percentage Of Participants With DGF, Functional DGF, And Immediate Graft Function
timeFrame: First 7 days post transplantation
measure: Percentage Of Participants Who Required Dialysis Post Transplantation
timeFrame: First 30 days post transplantation
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Day 28 post transplantation
measure: Percentage Of Participants With Rejection-free Graft Survival
timeFrame: Week 26 and 52 post transplantation
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Livingston
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Charleston
country: United States
state: South Carolina
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Camperdown
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Prague
country: Czechia
city: Bordeaux
country: France
city: Créteil
country: France
city: Le Kremlin-Bicêtre
country: France
city: Lyon
country: France
city: Nantes
country: France
city: Paris
country: France
city: Paris
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Hannoversch Münden
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Bari
country: Italy
city: Brescia
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Torino
country: Italy
city: Verona
country: Italy
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
References: