Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01336959
• Date of registration: 13/04/2011
• Prospective Registration: Yes
• Primary sponsor: Mereo BioPharma
• Public title: Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery
• Scientific 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)
• Date of first enrolment: September 2011
• Target sample size: 91
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01336959
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Israel, Taiwan, United States

Contacts

• Name: Jacqueline Parkin, PhD FRCP
• Affiliation: Mereo BioPharma

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Kidney Injury

Intervention(s)

Drug: BCT197 Part A

Drug: BCT197 Part B

Drug: Placebo

Primary Outcome(s)

Renal Function Measured at 48 Hours Post Cardiac Surgery With Cardiopulmonary Bypass Pump. [Time Frame: 48 hours]

Secondary Outcome(s)

Pharmacokinetic Measurements of Drug in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass Pump. Pharmacokinetics Will be Measured Using Cmax [Time Frame: 4 days]

Secondary ID(s)

CBCT197A2202

2011-002735-25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis

Results

• Results available: Yes
• Date Posted: 08/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01336959