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Trial record 1 of 1 for:    NCT02771509
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Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT02771509
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
Everest Clinical Research
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Angion Biomedica Corp

Tracking Information
First Submitted Date  ICMJE April 18, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE February 24, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • The maximum percent increase in sCr level from baseline [ Time Frame: Day 5 ]
  • The mean percent increase in serum creatinine above baseline over time [ Time Frame: starting from the end of CPB through Day 5, through Day 7, through Day 14, and through Day 30 ]
  • The mean percent increase of sCr above baseline [ Time Frame: at 24 hr after the end of CPB, and at Day 3, Day 4, Day 5, and Day 7 ]
  • The proportion of subjects who are diagnosed with AKI per KDIGO criteria [ Time Frame: through Day 5 ]
  • The proportion of subjects who are diagnosed with AKI per KDIGO criteria [ Time Frame: through Day 7 ]
  • Proportion of patients by severity of renal injury using KDIGO AKI staging [ Time Frame: at 24 hr after the end of CPB, at Day 3, at Day 4, Day 5, Day 7, Day 14, and Day 30 ]
  • The proportion of patients with AKI [ Time Frame: at 24 hr after the end of CPB, Day 3, Day 4, Day 5, Day 7 ]
  • Time in days from end of CPB to occurrence of AKI [ Time Frame: within Days 1-5 and within Days 1-7 ]
  • Time in days from the occurrence of AKI diagnosed postoperatively through Day 5 to recovery from AKI and through Day 7 to recovery from AKI [ Time Frame: through Day 5 to recovery from AKI and through Day 7 to recovery from AKI ]
  • Time in days to improvement in renal function [ Time Frame: from the day of occurrence of AKI diagnosed postoperatively through Day 5 and through Day 7 ]
  • the proportion of patients with renal function recovery, progression, or stabilization among patients with AKI diagnosed postoperatively [ Time Frame: at Day 30 ]
  • Among patients with AKI diagnosed postoperatively, the proportion of patients with renal function recovery, progression, or stabilization [ Time Frame: Through day 5 ]
  • The slope of decline of the creatinine curve [ Time Frame: from the day of peak sCr through Day 5, Day 7, Day 14 and Day 30 ]
  • Proportion of patients requiring initiation of any form of renal replacement therapy [ Time Frame: up to Day 30 ]
  • Length of index hospital stay [ Time Frame: through Day90 ]
  • Proportion of patients developing a composite endpoint comprising the following events: death, worsening of kidney function [ Time Frame: during the 30-day and 90-day post-operative periods ]
  • Changes from baseline in eGFR [ Time Frame: at Days 4, 7, 14, 30 and 90 ]
  • Proportion of patients having a ≥ 20 % reduction from baseline in eGFR [ Time Frame: at Days 2, 3, 4, 7, 14, and 30 and 90 ]
  • Maximal change from baseline in eGFR and sCr [ Time Frame: through Day 90 ]
  • Changes in circulating or urinary biomarkers of renal injury [ Time Frame: through Day 90 ]
  • Urine volume over 12-hour periods [ Time Frame: for the first 72 hours post-CPB ]
  • Cmax [ Time Frame: pre-dose, immediately after completing the 4th infusion, and at 2 hours and at 6 hours from the start of the 4th infusion ]
  • AUC [ Time Frame: pre-dose, immediately after completing the 4th infusion, and at 2 hours and at 6 hours from the start of the 4th infusion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Normal saline
    Other Name: Normal Saline
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ANG-3777
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2019)
240
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
100
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabrielle Pelle 516-326-1200 gpelle@angion.com
Listed Location Countries  ICMJE Brazil,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02771509
Other Study ID Numbers  ICMJE 002-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angion Biomedica Corp
Study Sponsor  ICMJE Angion Biomedica Corp
Collaborators  ICMJE
  • Everest Clinical Research
  • CTI Clinical Trial and Consulting Services
Investigators  ICMJE
Study Director: John Neylan, MD Angion Biomedica
PRS Account Angion Biomedica Corp
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP