Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Intervention: BCT197 Part A; Placebo; BCT197 Part B
Intervention description: open label single dose administration of 10mg BCT197, 2 hours prior to surgery; Single dose matching placebo administered 2 prior to surgery; BCT197 50mg single dose administered 2 hours prior to surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Acute Kidney Injury; Cardiopulmonary Bypass; CABG; Cardiac Surgery

Summary:

      This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients
      undergoing cardiac surgery with cardiopulmonary bypass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for elective cardiac surgery with CPB. Allowable procedures are
             CABG alone, aortic valve replacement or repair alone, mitral valve replacement or
             repair alone, CABG with aortic valve replacement or repair, and CABG with mitral valve
             replacement or repair. Patients with repeat surgery for any of the procedures can be
             included.

          -  Patients must weigh at least 50 kg to participate in the study, and must have a body
             mass index (BMI) 18 kg/m2

          -  Have an eGFR ≥ 30 and ≤ 60 mL/min/1.73 m2 to participate in Part A, or an eGFR > 60
             mL/min/1.73 m2 to participate in Part B. Upon completion of Part A, patients with eGFR
             ≥ 30 mL/min/1.73 m2 may participate in Part B, with dose administered as per the
             dosing table

        Exclusion Criteria:

          -  left ventricular ejection fraction, in the last 6 months, ≥30%

          -  Active systemic infection or uncontrolled diabetes mellitus with a glucose ≥250 mg% at
             the screening assessment

          -  Pregnant or nursing (lactating) women,

          -  Female subjects must either:

        have been surgically sterilized or hysterectomized at least 6 months prior to study
        participation, or have had surgical bilateral oophorectomy (with or without hysterectomy)
        or tubal ligation at least six weeks prior to study participation. In the case of
        oophorectomy alone, only when the reproductive status of the woman has been confirmed by
        follow- up hormone level assessment is she considered not of child bearing potential,
        Surgical sterilization procedures or hysterectomy must be supported with clinical
        documentation made available to the sponsor and noted in the Relevant Medical History /
        Current Medical Conditions section of the CRF, OR be postmenopausal. Female subjects are
        considered post-menopausal and not of child bearing potential if they have had 12 months of
        natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age
        appropriate, history of vasomotor symptoms). Female subjects 60 years of age or younger
        must confirm menopause by the demonstration of a plasma FSH level in the postmenopausal
        range according to the lab normal range. Documentation of a prior plasma FSH level is
        acceptable

          -  History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of
             drug abuse as indicated by the laboratory assays conducted during screening or
             baseline

          -  New cancer diagnosis with planned chemotherapy and/or radiation therapy, or cancer
             requiring ongoing chemotherapy and/or radiation therapy at the time of screening

        Other protocol-defined inclusion/exclusion criteria may apply