Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

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

Official Title
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A Two-part, Randomized, Double-blind, Placebo-controlled, Single Dose Study of BCT197 for the Prevention of Acute Kidney Injury (AKI) in Patients Undergoing Elective Cardiac Surgery With Cardiopulmonary Bypass (CPB)

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: BCT197 Part A
* Drug: Placebo
* Drug: BCT197 Part B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label - BCT197 Part A<br>10mg single dose of BCT197 | Drug: BCT197 Part A<br>* open label single dose administration of 10mg BCT197, 2 hours prior to surgery<br>|
| Experimental: BCT197 Part B<br>Single dose of 50mg BCT197 | Drug: BCT197 Part B<br>* BCT197 50mg single dose administered 2 hours prior to surgery<br>|
| Placebo Comparator: BCT 197 Placebo Part B<br>Single dose of matching placebo to 50mg BCT197 | Drug: Placebo<br>* Single dose matching placebo administered 2 prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function Measured at 48 Hours Post Cardiac Surgery With Cardiopulmonary Bypass Pump. | Median percent change from baseline in estimated Glomerular Filtration Rate (eGFR) at 48 hours postdose. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Measurements of Drug in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass Pump. Pharmacokinetics Will be Measured Using Cmax | Max serum concentration reached (ng/mL) | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Acute Kidney Injury, Cardiopulmonary Bypass, Cardiac Surgery