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

This study has been completed.
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02145182
First received: May 15, 2014
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Delayed Graft Function Drug: Eculizumab Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 not having biopsy proven acute rejection, graft loss or subject death


Enrollment: 286
Actual Study Start Date: July 2014
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

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

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 SCD or 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 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: aHUS, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02145182

  Show 77 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals
CTI Clinical Trial and Consulting Services
  More Information

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02145182     History of Changes
Other Study ID Numbers: ECU-DGF-201
2013-004650-25 ( EudraCT Number )
Study First Received: May 15, 2014
Last Updated: February 16, 2017

Keywords provided by Alexion Pharmaceuticals:
DGF
Dialysis
Kidney
Kidney Transplantation
eGFR
Complement
Eculizumab

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2017