- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01336959
Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Be'er Sheva, Israel, 84101
- Novartis Investigative Site
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Herzliya, Israel
- Novartis Investigative Site
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Jerusalem, Israel, 91031
- Novartis Investigative Site
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Petach Tikva, Israel, 49100
- Novartis Investigative Site
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Rehovot, Israel, 76100
- Novartis Investigative Site
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Tel-Aviv, Israel, 69710
- Novartis Investigative Site
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Taipei, Taiwan, 10002
- Novartis Investigative Site
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California
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Orange, California, United States, 92686
- Novartis Investigative Site
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Michigan
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Saginaw, Michigan, United States, 48601
- Novartis Investigative Site
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Nebraska
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Lincoln, Nebraska, United States, 68506
- Novartis Investigative Site
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Ohio
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Cleveland, Ohio, United States, 44195
- Novartis Investigative Site
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Pennsylvania
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Wynnewood, Pennsylvania, United States, 19096
- Novartis Investigative Site
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Virginia
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Falls Church, Virginia, United States, 22042
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Open Label - BCT197 Part A
10mg single dose of BCT197
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open label single dose administration of 10mg BCT197, 2 hours prior to surgery
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EXPERIMENTAL: BCT197 Part B
Single dose of 50mg BCT197
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BCT197 50mg single dose administered 2 hours prior to surgery
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PLACEBO_COMPARATOR: BCT 197 Placebo Part B
Single dose of matching placebo to 50mg BCT197
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Single dose matching placebo administered 2 prior to surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal Function Measured at 48 Hours Post Cardiac Surgery With Cardiopulmonary Bypass Pump.
Time Frame: 48 hours
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Median percent change from baseline in estimated Glomerular Filtration Rate (eGFR) at 48 hours postdose.
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48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pharmacokinetic Measurements of Drug in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass Pump. Pharmacokinetics Will be Measured Using Cmax
Time Frame: 4 days
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Max serum concentration reached (ng/mL)
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4 days
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBCT197A2202
- 2011-002735-25 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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