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
  Purpose

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


Condition Intervention Phase
Acute Kidney Injury
Drug: BCT197 Part A
Drug: Placebo
Drug: BCT197 Part B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function measured at 48 hours post cardiac surgery with cardiopulmonary bypass pump. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 83
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label - BCT197 Drug: BCT197 Part A
Experimental: Randomized double-blind BCT197 Drug: BCT197 Part B
Randomized Double-blind BCT197
Placebo Comparator: Randomized double-blind BCT 197 Placebo Drug: Placebo
Placebo capsules

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336959

Locations
United States, California
Novartis Investigative Site
Orange, California, United States, 92686
United States, Michigan
Novartis Investigative Site
Saginaw, Michigan, United States, 48601
United States, Nebraska
Novartis Investigative Site
Lincoln, Nebraska, United States, 68506
United States, Ohio
Novartis Investigative Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Novartis Investigative Site
Wynnewood, Pennsylvania, United States, 19096
United States, Virginia
Novartis Investigative Site
Falls Church, Virginia, United States, 22042
Israel
Novartis Investigative Site
Be'er Sheva, Israel, 84101
Novartis Investigative Site
Herzelia, Israel
Novartis Investigative Site
Jerusalem, Israel, 91031
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Rehovot, Israel, 76100
Novartis Investigative Site
Tel-Aviv, Israel, 69710
Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10002
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01336959     History of Changes
Other Study ID Numbers: CBCT197A2202, 2011-002735-25
Study First Received: April 13, 2011
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Acute Kidney Injury
Cardiopulmonary Bypass
CABG
Cardiac Surgery

Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014