Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

NCT ID: NCT01336959

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-11-30

Brief Summary

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

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Cardiopulmonary Bypass; CABG; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Open Label - BCT197 Part A

10mg single dose of BCT197

Group Type: EXPERIMENTAL

BCT197 Part A

Intervention Type: DRUG

open label single dose administration of 10mg BCT197, 2 hours prior to surgery

BCT197 Part B

Single dose of 50mg BCT197

Group Type: EXPERIMENTAL

BCT197 Part B

Intervention Type: DRUG

BCT197 50mg single dose administered 2 hours prior to surgery

BCT 197 Placebo Part B

Single dose of matching placebo to 50mg BCT197

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose matching placebo administered 2 prior to surgery

Interventions

BCT197 Part A

open label single dose administration of 10mg BCT197, 2 hours prior to surgery

Intervention Type: DRUG

Placebo

Single dose matching placebo administered 2 prior to surgery

Intervention Type: DRUG

BCT197 Part B

BCT197 50mg single dose administered 2 hours prior to surgery

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Mereo BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacqueline Parkin, PhD FRCP

Role: STUDY_DIRECTOR

Mereo BioPharma

Locations

Novartis Investigative Site

Orange, California, United States

Novartis Investigative Site

Saginaw, Michigan, United States

Novartis Investigative Site

Lincoln, Nebraska, United States

Novartis Investigative Site

Cleveland, Ohio, United States

Novartis Investigative Site

Wynnewood, Pennsylvania, United States

Novartis Investigative Site

Falls Church, Virginia, United States

Novartis Investigative Site

Beersheba, , Israel

Novartis Investigative Site

Herzliya, , Israel

Novartis Investigative Site

Jerusalem, , Israel

Novartis Investigative Site

Petah Tikva, , Israel

Novartis Investigative Site

Rehovot, , Israel

Novartis Investigative Site

Tel Aviv, , Israel

Novartis Investigative Site

Taipei, , Taiwan

Countries

United States; Israel; Taiwan

Other Identifiers

2011-002735-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBCT197A2202

Identifier Type: -

Identifier Source: org_study_id