Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02771509
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
Everest Clinical Research
Information provided by (Responsible Party):
Angion Biomedica Corp

Brief 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).

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: ANG-3777 Drug: Placebo Phase 2

Detailed Description:

Angion Biomedica Corp. has developed a small molecule hepatocyte growth factor/scatter factor (HGF/SF) mimetic, termed ANG-3777, which exerts significant nephroprotective effects in several preclinical renal injury models. Angion intends to develop ANG-3777 as a therapy to prevent and/or treat acute kidney injury. ANG-3777 is a new molecular entity and the proposed treatment is novel since no drug is currently available with an indication to prevent and/or treat acute kidney injury.

This is a randomized, prospective, parallel-group, double-blind, placebo-controlled, multicenter study. Patients who will be undergoing a surgical procedure involving CPB and are at elevated risk pre-surgery for AKI will be eligible to participate in the study. Patients will be randomized 1:1 to receive either ANG-3777 or placebo (normal saline) immediately after surgery. Study 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.

Patients will be followed for safety, PK (in a subset of patients), and efficacy up to Day 90, with Day 1 being the day of the first infusion of study drug. Patients will be assessed daily through Day 7 and then on Days 14, 30 and 90.

Efficacy endpoints include assessment of post-CPB renal injury, expressed as percent increase in sCr above Baseline over time and the maximum percent increase in sCr following CPB, from 24 hours after end of CPB through Day 5; the proportion of patients reaching each KDIGO stage or having no AKI at specified time points through Day 30; and analyses among patients who develop AKI assessing time to recovery or reduction in KDIGO stage.

Approximately 240 patients will be randomized; 120 patients will be randomized to BB3 and 120 patients to placebo.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : December 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: ANG-3777
Study 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.
Drug: ANG-3777
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
Other Name: Hepatocyte growth factor mimetic

Placebo Comparator: Normal Saline
The 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.
Drug: Placebo
Other Name: Normal Saline




Primary Outcome Measures :
  1. 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 5 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is either male or female ≥ 18 years.
  2. Patient has provided written informed consent, and is willing and able to comply with the requirements of the study protocol, including screening procedures.
  3. Patient must be scheduled for and undergo a non-emergent cardiac surgical procedure involving CPB. Eligible procedures include:

    1. Coronary artery bypass graft (CABG) alone
    2. Aortic valve replacement or repair alone, with or without aortic root repair
    3. Mitral, tricuspid, or pulmonic valve replacement or repair alone
    4. Combined replacement of several cardiac valves
    5. CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
    6. CABG with combined cardiac valve replacement or repair.
  4. Patient must have the following risk factor(s) for AKI prior to surgery:

    1. Estimated glomerular filtration rate (eGFR) of ≥ 20 and < 30 ml/min/1.73m2, or
    2. eGFR ≥ 30 and < 60 mL/min/1.73m2 and ONE of the following Additional Risk Factors (other than age ≥ 75 years), or
    3. 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.
  5. 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.
  6. Patient's body mass index (BMI) < 40 at Screening.

Exclusion Criteria:

  1. Patient has eGFR < 20 mL/min/1.73 m2 within 48 hours pre-surgery as measured by MDRD 4.
  2. 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.
  3. Currently active infection requiring antibiotic treatment.
  4. 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.
  5. Administration of iodinated contrast material within 24 hours prior to cardiac surgery.
  6. Patients diagnosed with AKI as defined by KDIGO criteria within 48 hours prior to surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771509


Contacts
Layout table for location contacts
Contact: Gabrielle Pelle 516-326-1200 gpelle@angion.com

Locations
Layout table for location information
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
California Institute of Renal Reseach Recruiting
San Diego, California, United States, 92123
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
UF Health at Unviersity of Florida Recruiting
Gainesville, Florida, United States, 32610
River City Clinical Research Recruiting
Jacksonville, Florida, United States, 32207
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
United States, Michigan
MidMichigan Medical Center Midland Recruiting
Midland, Michigan, United States, 49770
Cardiac & Vascular Research Center of Northern Michigan Recruiting
Petoskey, Michigan, United States, 49770
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Fairview Recruiting
Cleveland, Ohio, United States, 44111
United States, Texas
Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center Recruiting
Dallas, Texas, United States, 75226
Sponsors and Collaborators
Angion Biomedica Corp
Everest Clinical Research
Investigators
Layout table for investigator information
Study Director: John Neylan, MD Angion Biomedica

Layout table for additonal information
Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT02771509     History of Changes
Other Study ID Numbers: 002-15
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Keywords provided by Angion Biomedica Corp:
CPB
Cardiac Surgery
Acute Kidney Injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases