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Delayed Graft FunctionPhase 2NCT01919346

Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation

A Phase 2 study testing Eculizumab and Normal Saline in people with Delayed Graft Function and Kidney Transplantation, run by Heeger, Peter, M.D. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of Eculizumab in the prevention of Delayed Graft Function following deceased donor kidney transplantation. Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion (IR) injury, it is… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Eculizumab and Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
5 sitesUnited States
Study dates
Aug 2013to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age 18 years or older
  • Weight > 40 kg
  • Male or Female
  • Recipient of first deceased donor kidney
  • Able to provide written informed consent
  • Transplant candidate as per site specific guidelines
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  • Dialysis dependent renal failure (initiated more than 2 months prior to transplant)
  • Recipients of kidneys defined as:
  • Extended Criteria Donor (ECD) kidney with brain death: Kidney donors 60 years of age or older; or donors aged 50-59 years and have two of the following features: Hypertension, terminal serum creatinine > 1.5 mg/dL, or death from cerebrovascular accident (CVA), OR
  • Standard Criteria Donor (SCD) kidney with actual cold ischemia time (CIT) 18 - 40 hours

Who cannot join

  • Patient is planned to receive a multi-organ transplant
  • Kidney from donor < 6 years of age
  • Dual kidney transplant (from same donor, including en bloc)
  • Living donor kidney transplant
  • Recipients with donor-specific anti-HLA antibodies of more than 3,000 MFI
  • Participation in another investigational drug study
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  • Recipient BMI > 40
  • ABO incompatible
  • DCD (donor with cardiac death) Donor
  • Women who are pregnant or breast-feeding
  • Women of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception (defined as the use of oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD)or intrauterine system (IUS), barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository)
  • Patients with HBsAg-positive status, HCV infection, or HIV infection
  • Patients with atypical hemolytic uremic syndrome (aHUS) or C3 glomerulonephritis (C3GN)
  • Active bacterial or other infection which is clinically significant in the opinion of the investigator
  • Patients with history of splenectomy
  • Patients with history of meningococcal disease
  • Patients allergic to or unable to tolerate Ciprofloxacin
  • Patients unable or unwilling to receive vaccination against meningitis prior to study drug administration
  • Patients with a known or suspected hereditary complement deficiency
  • Patients with a history of cancer (other than non melanoma skin cancers) within the last five years
  • Donors of more than 70 years of age
  • Subjects with a psychiatric or physical illness which in the opinion of the Investigator would interfere with their ability to participate in the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Yale - New Haven Hospital

    New Haven, Connecticut, 06540

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Montefiore Medical Center

    New York, New York, 10467

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Eculizumab for Prevention of Delayed Graft Function in Deceased Donor Kidney Transplantation

The purpose of this study is to evaluate the efficacy of Eculizumab in the prevention of Delayed Graft Function following deceased donor kidney transplantation. Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion (IR) injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is further hypothesized that Eculizumab, a humanized monoclonal antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent IR injury in high risk recipients. This trial is a prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation and once again 24 hours later in preventing delayed graft function in first adult recipients of deceased donor kidneys.

Being tested
Eculizumab, Normal Saline
Keywords
Kidney Transplantation, Delayed Graft Function
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

  • Normal SalineDrug

Study groups in NCT01919346
Study groupRoleWhat they receive
EculizumabExperimentalEculizumab 1200 mg (diluted in Sodium Chloride (NaCl) to 5mg/mL, volume = 240 mL) will be given intraoperatively at the time of transplantation prior to reperfusion of the renal allograft and again at 900 mg (diluted in NaCl to 5mg/mL, volume = 180 mL) 12-24 hours post-transplantation
Receives: Drug: Eculizumab
Normal SalinePlacebo comparatorAdministered at same volume and time as Experimental arm
Receives: Drug: Normal Saline

What is being measured

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

  1. Hemodialysis

    The need of at least one dialysis treatment during the first 7 days after transplantation excluding: (i) requirement for a single dialysis session indicated for hyperkalemia (ii) hyperacute rejection, renal arterial and/or venous thrombosis, obstructive uropathy, recurrence of primary disease, and early thrombotic microangiopathy

    Measured: 7 days post-transplantation

Secondary outcomes (10)

  1. Estimated Glomerular Filtration Rate (GFR)

    Estimated GFR as determined from the 4-variable MDRD (Modified Diet in Renal Disease) equation on days 7, 30, 90 and 180 post-transplantation

    Measured: 6 months post-transplantation

  2. Hemodialysis

    Number of dialysis sessions at 30 days and 8 weeks post-transplantation

    Measured: 8 weeks post-transplantation

  3. Primary Non-function

    The incidence of primary non-function (PNF) defined as the need for dialysis-dependency for more than 8 weeks

    Measured: 8 weeks post-transplantation

  4. Graft Rejection

    Incidence of graft rejection within 6 months

    Measured: 6 months post-transplantation

  5. Patient Survival

    Patient survival at 12 months post-transplantation

    Measured: 12 months post-transplantation

  6. Graft Survival

    Death censored graft survival at 12 months post-transplantation

    Measured: 12 months post-transplantation

  7. Serum Creatinine

    Change from baseline in serum creatinine and serum creatinine concentration at 24, 48 and 72 hours post-transplantation

    Measured: 3 days post-transplantation

  8. Urine Output

    Percentage of patients with total 24-hour urine output of more than 500 mL on post-transplantation days 2 and 3

    Measured: 3 days post-transplantation

  9. Biomarkers

    Absolute levels of biomarkers associated with acute renal injury

    Measured: 6 months post-transplantation

  10. Qualified Delayed Graft Function (qDGF)

    The incidence of qDGF defined as the requirement for dialysis for any reason in the first 7 days post-transplantation

    Measured: 7 days 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 posted9 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: Based on results from Alexion PROTECT DGF study

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919346
Sponsor's protocol ID
13-0920
Status last verified
Feb 2018
First submitted
7 Aug 2013
Last updated
27 Feb 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eculizumab and Normal Saline in people with Delayed Graft Function and Kidney Transplantation, run by Heeger, Peter, M.D. at 5 sites in United States.

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 10 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: stopped early, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 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.

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

Are results available for this study?

The study was stopped early (reason given: Based on results from Alexion PROTECT DGF study). Results are not available in the source record.

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?

Hemodialysis (time frame: 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 NCT01919346.

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 27 Feb 2018.

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