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Phase II

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

  • Study HIC#:2000022654
  • Last Updated:07/15/2021

Brief Summary:

The objective of the study is to assess the safety and efficacy of BB3 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).

  • Age18 years and older
  • GenderBoth
  • Start Date10/22/2018
  • End Date12/31/2017

Trial Purpose and Description

The objective of the study is to assess the safety and efficacy of BB3 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).

Eligibility 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) 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) < 35 at Screening.
  7. Female patients of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year):
    1. Must have a negative serum pregnancy test prior to surgery.
    2. Must agree (1) to use 2 forms of effective birth control regimen (at least one-barrier method) during the 90-day study period or (2) to maintain total abstinence throughout the 90-day study period.
  8. Male patients must agree to use condoms or other suitable means of pregnancy prevention such as abstinence during the 90-day study period.

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 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 48 hours prior to cardiac surgery.
  6. Patients diagnosed with AKI as defined by KDIGO criteria within 48 hours prior to surgery.
  7. Cardiogenic shock or hemodynamic instability within 24 hours prior to randomization, defined as SBP < 80 mmHg and pulse > 120 beats/min and requirement for inotropes or vasopressors or other mechanical devices such as IABP.
  8. Need for any of the following within 7 days prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, left ventricular assist device (LVAD), or other form of mechanical circulatory support.
  9. Required cardiopulmonary resuscitation within 7 days prior to cardiac surgery.
  10. Female patient who is lactating or breast feeding.
  11. Patient has history of positive human immunodeficiency virus (HIV) test.
  12. Requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin (Cipro®) and/or fluvoxamine (Luvox®).
  13. Patient is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
  14. Patient is not deemed medically stable for the study in the opinion of the Investigator or the subject's primary nephrologist.
  15. Patient with a clinical or laboratory diagnosis of shock liver.
  16. Exclusion criteria during surgery:

Patients who have a procedure during surgery or experience an intra-operative complication which, in the opinion of the Investigator, precludes dosing of the patient with study drug; examples include implantation of an IABP or LVAD, acute myocardial infarction, cardiac arrest during surgery, and procedure-associated decrease in ejection fraction.

Principal Investigator

Sub-Investigators

  • Hossam Tantawy

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