Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01336959
First received: April 13, 2011
Last updated: February 24, 2014
Last verified: February 2014

April 13, 2011
February 24, 2014
September 2011
November 2013   (final data collection date for primary outcome measure)
Renal function measured at 48 hours post cardiac surgery with cardiopulmonary bypass pump. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01336959 on ClinicalTrials.gov Archive Site
Pharmacokinetic measurements of drug in patients undergoing cardiac surgery with cardiopulmonary bypass pump. Pharmacokinetics will be measured using AUC, Cmax, and Tmax. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Kidney Injury
  • Drug: BCT197 Part A
  • Drug: Placebo
    Placebo capsules
  • Drug: BCT197 Part B
    Randomized Double-blind BCT197
  • Experimental: Open Label - BCT197
    Intervention: Drug: BCT197 Part A
  • Experimental: Randomized double-blind BCT197
    Intervention: Drug: BCT197 Part B
  • Placebo Comparator: Randomized double-blind BCT 197 Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
November 2013
November 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel,   Taiwan
 
NCT01336959
CBCT197A2202, 2011-002735-25
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2014

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