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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02145182
First Posted: May 22, 2014
Last Update Posted: September 13, 2017
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.
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Alexion Pharmaceuticals
May 15, 2014
May 22, 2014
September 13, 2017
July 2014
November 2016   (Final data collection date for primary outcome measure)
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.
Incidence of 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.
Complete list of historical versions of study NCT02145182 on ClinicalTrials.gov Archive Site
  • Graft function categorized into delayed graft function, functional delayed graft function, and immediate graft function [ Time Frame: During the first 7 days post-transplantation ]
  • Dialysis post-transplantation [ Time Frame: During the first 30 days post-transplantation ]
  • Calculated Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: At day 28 post-transplantation ]
  • 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
  • Graft function categorized into delayed graft function, functional delayed graft function, and immediate graft function [ Time Frame: During the first 7 days post-transplantation ]
  • Dialysis post-transplantation [ Time Frame: During the first 30 days post-transplantation ]
  • Calculated eGFR (Estimated Glomerular Filtration Rate) [ Time Frame: At day 28 post-transplantation ]
  • Rejection free graft survival [ Time Frame: At 26 and 52 weeks post-transplantation ]
    Rejection free graft survival defined as freedom from biopsy proven acute rejection, graft loss or subject death
Not Provided
Not Provided
 
Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
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.
The purpose of this study is to determine if Eculizumab is safe and could be used to prevent delayed graft function following kidney transplantation.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Delayed Graft Function
  • 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
  • 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).
  • 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).
    Intervention: Drug: Eculizumab
  • 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).
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
286
November 2016
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czechia,   France,   Germany,   Italy,   Spain,   United States
Czech Republic
 
NCT02145182
ECU-DGF-201
2013-004650-25 ( EudraCT Number )
Yes
Not Provided
Not Provided
Alexion Pharmaceuticals
Alexion Pharmaceuticals
CTI Clinical Trial and Consulting Services
Not Provided
Alexion Pharmaceuticals
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP