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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02145182
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : September 13, 2017
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Alexion Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Delayed Graft Function Drug: Eculizumab Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : July 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab

Arm Intervention/treatment
Experimental: Active
Eculizumab will be administered by intravenous (IV) infusion over 25-45 minutes for two doses (on day of transplant then 18-24 hours later).
Drug: Eculizumab
Eculizumab will be administered by intravenous (IV) infusion over 25-45 minutes for two doses (on day of transplant then 18-24 hours later).
Other Name: soliris

Placebo Comparator: Placebo
Placebo will be administered by intravenous (IV) infusion over 25-45 minutes for two doses (on day of transplant then 18-24 hours later).
Drug: Placebo
Placebo will be administered by intravenous (IV) infusion over 25-45 minutes for two doses (on day of transplant then 18-24 hours later).

Primary Outcome Measures :
  1. Incidence of delayed graft function (DGF) defined as the requirement for dialysis for any reason in the first seven days post-transplant [ Time Frame: First 7 days post Kidney Transplant ]
    The primary objective is to demonstrate efficacy and safety of a two dose regimen of eculizumab to prevent DGF in adult recipients of diseased donor kidney transplants who are at increased risk of DGF.

Secondary Outcome Measures :
  1. Graft function categorized into delayed graft function, functional delayed graft function, and immediate graft function [ Time Frame: During the first 7 days post-transplantation ]
  2. Dialysis post-transplantation [ Time Frame: During the first 30 days post-transplantation ]
  3. Calculated Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: At day 28 post-transplantation ]
  4. Rejection free graft survival [ Time Frame: At 26 and 52 weeks post-transplantation ]
    Rejection free graft survival defined as not having biopsy proven acute rejection, graft loss or subject death

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 standard criteria donor (SCD) or expanded criteria donor (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 antibody-mediated rejection [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: atypical hemolytic uremic syndrome [aHUS], paroxysmal nocturnal hemoglobinuria [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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02145182

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix, Arizona, United States, 85054
United States, California
Los Angeles, California, United States, 90024
Palo Alto, California, United States, 94304
San Francisco, California, United States, 94115
San Francisco, California, United States, 94143
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Tampa, Florida, United States, 33606
United States, Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Livingston, New Jersey, United States, 07039
United States, New York
New York, New York, United States, 10032
New York, New York, United States, 10065
The Bronx, New York, United States, 10467
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77030
United States, Virginia
Charlottesville, Virginia, United States, 22903
Richmond, Virginia, United States, 23298
United States, Washington
Seattle, Washington, United States, 98195
Australia, New South Wales
Camperdown, New South Wales, Australia
Westmead, New South Wales, Australia
Australia, South Australia
Adelaide, South Australia, Australia
Australia, Victoria
Clayton, Victoria, Australia, 3168
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Prague, Czechia, 14000
Bordeaux, France, 33076
Créteil, France, 94010
Le Kremelin-Bicêtre, France, 94270
Lyon, France, 69003
Nantes, France, 44093
Paris, France, 75010
Paris, France, 75743
Strasburg, France, 67091
Suresnes, France, 92150
Toulouse, France, 31059
Tours, France, 37044
Berlin, Germany, 13353
Dresden, Germany, 01307
Erlangen, Germany, 91054
Essen, Germany, 45147
Hamburg, Germany, 20246
Hannoversch Münden, Germany, 34346
Hannover, Germany, 30625
Kiel, Germany, 24105
Bari, Italy, 70124
Brescia, Italy, 25123
Milano, Italy, 20162
Padova, Italy, 35128
Torino, Italy, 10126
Verona, Italy, 37126
Badalona, Spain, 08916
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08907
Madrid, Spain, 28041
Santander, Spain, 39008
Sevilla, Spain, 41013
Valencia, Spain, 46017
Valencia, Spain, 46026
Zaragoza, Spain, 50009
Sponsors and Collaborators
Alexion Pharmaceuticals
CTI Clinical Trial and Consulting Services

Responsible Party: Alexion Pharmaceuticals Identifier: NCT02145182     History of Changes
Other Study ID Numbers: ECU-DGF-201
2013-004650-25 ( EudraCT Number )
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Alexion Pharmaceuticals:
Kidney Transplantation

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes