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Acute Kidney InjuryPhase 2NCT02771509

Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass

A Phase 2 study testing ANG-3777 in people with Acute Kidney Injury, run by Angion Biomedica Corp at 40 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of the study is to assess the safety and efficacy of ANG-3777 in preventing AKI compared to placebo when administered to patients at risk for developing acute kidney injury (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury
What is being tested?
ANG-3777
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
275 participants
Where
40 sitesin 4 countries
Study dates
24 Feb 2017to Aug 2021
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

  • Patient is either male or female ≥ 18 years.
  • Patient has provided written informed consent, and is willing and able to comply with the requirements of the study protocol, including screening procedures.
  • Patient must be scheduled for and undergo a non-emergent cardiac surgical procedure involving CPB. Eligible procedures include:
  • Coronary artery bypass graft (CABG) alone
  • Aortic valve replacement or repair alone, with or without aortic root repair
  • Mitral, tricuspid, or pulmonic valve replacement or repair alone
Show all 24Show fewer
  • Combined replacement of several cardiac valves
  • CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
  • CABG with combined cardiac valve replacement or repair.
  • Patient must have the following risk factor(s) for AKI prior to surgery:
  • Estimated glomerular filtration rate (eGFR) of ≥ 20 and < 30 ml/min/1.73m2, or
  • eGFR ≥ 30 and < 60 mL/min/1.73m2 and ONE of the following Additional Risk Factors (other than age ≥ 75 years), or
  • eGFR ≥ 60 ml/min/1.73m2 and TWO of the following Additional Risk Factors
  • eGFR will be calculated using the abbreviated MDRD equation (MDRD-4, often referred to as the Levey equation): eGFR = 186.3 x sCr-1.154 x Age-0.203 x [0.742 if Female] x [1.212 if Black]
  • Additional Risk Factors:
  • Combined valve and coronary surgery
  • Previous cardiac surgery with sternotomy
  • Left ventricular ejection fraction (LVEF) < 35% by invasive or noninvasive diagnostic cardiac imaging within 90 days prior to surgery
  • Diabetes mellitus requiring insulin treatment
  • Non-insulin-requiring diabetes with documented presence of at least moderate (+2 or > 100 mg/dL) proteinuria on urine analysis (medical history or dipstick)
  • Documented NYHA Class III or IV within 1 year prior to index surgery
  • Age ≥ 75 years can be considered an Additional Risk Factor only for patients with eGFR ≥ 60 ml/min/1.73m2.
  • Patient must have presented for surgery without prior evidence of active renal injury defined as no acute rise in sCr > 0.3 mg/dL or no 50% increase in sCr between the time of Screening and pre-surgery.
  • Patient's body mass index (BMI) < 40 at Screening.

Who cannot join

  • Patient has eGFR < 20 mL/min/1.73 m2 within 48 hours pre-surgery as measured by MDRD 4.
  • Patient has ongoing sepsis or partially treated infection. Sepsis is defined as the presence of a confirmed pathogen, along with fever or hypoperfusion (i.e., acidosis and new onset elevation of liver function tests) or hypotension requiring pressor use prior to surgery.
  • Currently active infection requiring antibiotic treatment.
  • Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
  • Administration of iodinated contrast material within 24 hours prior to cardiac surgery.
  • Patients diagnosed with AKI as defined by KDIGO criteria within 48 hours prior to surgery.

Trial locations and contacts

40 sites in 4 countries.

40 sites in 4 countries

United States23 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • TriHealth

    Cincinnati, Ohio, 45220

  • Cleveland Clinic Fairview

    Cleveland, Ohio, 44111

  • Ohio State Wexner Medical Center

    Columbus, Ohio, 43210

  • Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center

    Dallas, Texas, 75226

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University

    Durham, North Carolina, 27710

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32207

  • Indiana Ohio Heart

    Fort Wayne, Indiana, 46804

  • UF Health at Unviersity of Florida

    Gainesville, Florida, 32610

  • River City Clinical Research

    Jacksonville, Florida, 32207

  • Bryan Heart

    Lincoln, Nebraska, 68506

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • MidMichigan Medical Center Midland

    Midland, Michigan, 49770

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Columbia University Medical Center

    New York, New York, 10032

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Cardiac & Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • California Institute of Renal Reseach

    San Diego, California, 92123

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada6 sites

  • London Health Sciences Center

    London, Ontario, N6A 5A5

  • CHUM - Hôtel Dieu

    Montreal, Quebec, H2W 1T8

  • MUHC - Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, G1V 4G5

  • St. John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saint Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Georgia6 sites

  • Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • New Hospitals LTD

    Tbilisi, 0114

  • Bokhua Memorial Cardiovascular Center

    Tbilisi, 0159

  • Jerarsi JSC

    Tbilisi, 0167

  • Tbilisi Heart Center

    Tbilisi, 0186

  • Acad. G. Chapidze Emergency Cardiology Center

    Tbilisi, 0519

Other trials in Georgia

Brazil5 sites

  • Faculdade de Medicina da UNESP Campus de Botucatu

    Botucatu, 18618-686

  • Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC - FUC)

    Porto Alegre, 90040-371

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)

    Ribeirão Preto, 14048-900

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, 15090-000

  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor - HCFMUSP)

    São Paulo, 05403-000

Other trials in Brazil

About this study

Official title: A Multicenter, Prospective, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of ANG-3777 to Assess the Safety and Efficacy of BB3 in Patients Developing Acute Kidney Injury After Cardiac Surgery

The objective of the study is to assess the safety and efficacy of ANG-3777 in preventing AKI compared to placebo when administered to patients at risk for developing acute kidney injury (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB).

Being tested
ANG-3777, Placebo
Keywords
CPB, Cardiac Surgery, Acute Kidney Injury
Medical subject headings
Acute Kidney Injury

What participants receive

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

  • ANG-3777Drug

    Also called Hepatocyte growth factor mimetic

    6 mg/mL BB3, IV, 4 days in a row, first dose must be within 4 hours after surgery, the next three doses will be approx. 24 hours after the last dose

  • PlaceboDrug

    Also called Normal Saline

    Normal saline

Study groups in NCT02771509
Study groupRoleWhat they receive
ANG-3777Active comparatorStudy drug will be administered for a total of 4 daily intravenous (IV) infusions. The first post-operative dose MUST be started within 4 hours of completing CPB. The second dose will be administered 24 ± 2 hours after completing CPB, and the third and fourth doses will be administered 24 ± 2 hours after each previous dose. Duration of administration is 30 minutes.
Receives: Drug: ANG-3777
Normal SalinePlacebo comparatorThe placebo will be administered for a total of 4 daily intravenous (IV) infusions. The first post-operative dose MUST be started within 4 hours of completing CPB. The second dose will be administered 24 ± 2 hours after completing CPB, and the third and fourth doses will be administered 24 ± 2 hours after each previous dose. Duration of administration is 30 minutes.
Receives: Drug: Placebo

What is being measured

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

  1. The mean AUC of the percent increase in serum creatinine above baseline

    Measured: starting from 24 hr after the end of CPB through Day 6

Timeline

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

  1. First posted13 May 2016 (estimated)
  2. Study start24 Feb 2017
  3. Primary completionAug 2021 (estimated)
  4. Study completionAug 2021 (estimated)

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02771509
Sponsor's protocol ID
002-15
Status last verified
Jul 2021
First submitted
18 Apr 2016
Last updated
15 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ayad SS, Beaver T, Corteville D, Swaminathan M, Pearl RG, Aslam S, Csomor PA, Alperovich G, Neylan J. Development of and recovery from acute kidney injury after cardiac surgery: Randomized phase 2 trial of the hepatocyte growth factor mimetic ANG-3777. J Thorac Cardiovasc Surg. 2025 Oct;170(4):1125-1132.e2. doi: 10.1016/j.jtcvs.2024.11.024. Epub 2024 Nov 26.

    PubMed 39603491

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ANG-3777 in people with Acute Kidney Injury, run by Angion Biomedica Corp at 40 sites in 4 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 24 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Canada, Georgia, Brazil. 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?

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?

The mean AUC of the percent increase in serum creatinine above baseline (time frame: starting from 24 hr after the end of CPB through Day 6). 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 NCT02771509, 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 15 Jul 2021.

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