Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

Acute Kidney Injury Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01336959
• Other study ID #: CBCT197A2202
• Secondary ID: 2011-002735-25
• Status: Terminated
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2020
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• BCT197 Part A
open label single dose administration of 10mg BCT197, 2 hours prior to surgery
• Placebo
Single dose matching placebo administered 2 prior to surgery
• BCT197 Part B
BCT197 50mg single dose administered 2 hours prior to surgery

Locations

Country	Name	City	State
Israel	Novartis Investigative Site	Be'er Sheva
Israel	Novartis Investigative Site	Herzliya
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Rehovot
Israel	Novartis Investigative Site	Tel-Aviv
Taiwan	Novartis Investigative Site	Taipei
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Falls Church	Virginia
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Saginaw	Michigan
United States	Novartis Investigative Site	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Mereo BioPharma	Novartis

Countries where clinical trial is conducted

United States,  Israel,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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