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Delayed Graft FunctionPhase 2/3NCT02145182

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

A Phase 2/3 study testing Eculizumab in people with Delayed Graft Function, run by Alexion Pharmaceuticals, Inc. at 78 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delayed Graft Function
What is being tested?
Eculizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
78 sitesin 9 countries
Study dates
21 Aug 2014to 22 Nov 2016
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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 locations and contacts

78 sites in 9 countries.

78 sites in 9 countries

United States32 sites

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlottesville, Virginia, 22903

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Houston, Texas, 77030

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Livingston, New Jersey, 07039

  • Study site

    Los Angeles, California, 90024

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10032

  • Study site

    New York, New York, 10065

  • Study site

    Palo Alto, California, 94304

  • Study site

    Phoenix, Arizona, 85054

  • Study site

    Richmond, Virginia, 23298

  • Study site

    San Francisco, California, 94115

  • Study site

    San Francisco, California, 94143

  • Study site

    Seattle, Washington, 98195

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Tampa, Florida, 33606

  • Study site

    The Bronx, New York, 10467

  • Study site

    Washington D.C., District of Columbia, 20007

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

France11 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Créteil, 94010

  • Study site

    Le Kremlin-Bicêtre, 94270

  • Study site

    Lyon, 69003

  • Study site

    Nantes, 44093

  • Study site

    Paris, 75010

  • Study site

    Paris, 75743

  • Study site

    Strasbourg, 67091

  • Study site

    Suresnes, 92150

  • Study site

    Toulouse, 31059

  • Study site

    Tours, 37044

Other trials in France

Spain11 sites

  • Study site

    Badalona, 08916

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08907

  • Study site

    Madrid, 28041

  • Study site

    Santander, 39008

  • Study site

    Seville, 41013

  • Study site

    Valencia, 46017

  • Study site

    Valencia, 46026

  • Study site

    Zaragoza, 50009

Other trials in Spain

Germany8 sites

  • Study site

    Berlin, 13353

  • Study site

    Dresden, 01307

  • Study site

    Erlangen, 91054

  • Study site

    Essen, 45147

  • Study site

    Hamburg, 20246

  • Study site

    Hannoversch Münden, 34346

  • Study site

    Hanover, 30625

  • Study site

    Kiel, 24105

Other trials in Germany

Italy6 sites

  • Study site

    Bari, 70124

  • Study site

    Brescia, 25123

  • Study site

    Milan, 20162

  • Study site

    Padova, 35128

  • Study site

    Torino, 10126

  • Study site

    Verona, 37126

Other trials in Italy

Australia4 sites

  • Study site

    Adelaide, South Australia

  • Study site

    Camperdown, New South Wales

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Westmead, New South Wales

Other trials in Australia

Canada4 sites

  • Study site

    Halifax, Nova Scotia

  • Study site

    Montreal, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Brazil1 site

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 05403-000

Other trials in Brazil

Czechia1 site

  • Study site

    Prague, 14000

Other trials in Czechia

About this 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.

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.

Being tested
Eculizumab, Placebo
Keywords
DGF, Dialysis, Kidney, Kidney Transplantation, eGFR, Complement, Eculizumab
Medical subject headings
Delayed Graft Function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EculizumabDrug

    Also called Soliris

    Eculizumab is a complement component 5 inhibitor.

  • PlaceboDrug

    0.9% sodium chloride

Study groups in NCT02145182
Study groupRoleWhat they receive
ActiveExperimentalEculizumab 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).
Receives: Drug: Eculizumab
PlaceboPlacebo comparatorPlacebo was administered by IV infusion over 25-45 min for 2 doses (on the day of transplant then 18-24 h later).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant

    Results are reported for the DGF composite endpoint, defined as the occurrence of DGF (dialysis for any reason in the first 7 days post transplantation), graft loss, death, or loss to follow-up (including discontinuation) in the first 7 days post transplantation and for each item of the composite endpoint. Loss to follow-up included withdrawal due to any reason other than death. The sum of the counts in the events that make up the DGF composite may be greater than the composite count, because a participant who experienced multiple events was only counted once in the composite.

    Measured: First 7 days post transplantation

Secondary outcomes (4)

  1. Percentage Of Participants With DGF, Functional DGF, And Immediate Graft Function

    DGF was defined as a requirement for dialysis for any reason in the first 7 days post transplantation; functional DGF was defined as no need for dialysis during the first 7 days post transplantation and either (1) a <70% reduction in serum creatinine during the first 7 days post transplantation, or (2) failure of serum creatinine to decrease by at least 10% daily on 3 consecutive days, both measured during the first 7 days post transplantation. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.

    Measured: First 7 days post transplantation

  2. Percentage Of Participants Who Required Dialysis Post Transplantation

    The need for dialysis was assessed by evaluation of renal function; this included urine volume, blood urea nitrogen, serum creatinine, and, starting on Day 2, the creatinine reduction ratio. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.

    Measured: First 30 days post transplantation

  3. Estimated Glomerular Filtration Rate (eGFR)

    The eGFR was calculated by using the Modification of Diet in Renal Disease 7 equation at Day 28 post transplantation. The equation requires serum creatinine, age, ethnicity, gender, blood urea nitrogen, and albumin. The eGFR was calculated retrospectively from participant demographics and laboratory chemistries and is reported in mL/min/square meter (m^2).

    Measured: Day 28 post transplantation

  4. Percentage Of Participants With Rejection-free Graft Survival

    Graft survival was defined as not having biopsy-proven acute rejection per Banff criteria, graft loss, or participant death. Participants who did not experience graft loss or death were censored at 365 days or the day they withdrew, whichever came first. There were no time-specific protocol mandated biopsies. Kidney biopsy would have been performed for cause at the discretion of the Investigator to assess poor graft function and would have been obtained prior to initiating treatment of suspected allograft rejection. Only summaries of Kaplan-Meier estimates of graft survival at Week 26 (Month 6) and Week 52 (Month 12) are reported.

    Measured: Week 26 and 52 post transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2014 (estimated)
  2. Study start21 Aug 2014
  3. Primary completion22 Nov 2016
  4. Study completion22 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145182
Sponsor's protocol ID
ECU-DGF-201
Other IDs
2013-004650-25
Status last verified
Dec 2018
First submitted
15 May 2014
Last updated
17 Dec 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Marks WH, Patel A, Viklicky O, Glotz D, Ratner LE, Vincenti F, Cruzado JM, Galijasevic ST, Jiang X, Ogawa M, Haller H, Moreso F, Nguefouet Momo RE, Formica RN, Gill JS, Irish W. Evaluation of eculizumab for the prevention of delayed graft function after kidney transplantation in adults: A randomized, double-blind, placebo-controlled trial. Am J Transplant. 2026 Sep 19:S1600-6135(26)02784-X. doi: 10.1016/j.ajt.2026.09.024. Online ahead of print.

    PubMed 42763038

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Eculizumab in people with Delayed Graft Function, run by Alexion Pharmaceuticals, Inc. at 78 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, France, Spain, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant (time frame: First 7 days post transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02145182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

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