Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

NCT01336959 | Terminated Phase 2 Results DMC

• 2 other identifiers: CBCT197A22022011-002735-25
• Study Type: interventional
• Target: 91
• Locations: 3 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacokinetic Measurements of Drug in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass Pump. Pharmacokinetics Will be Measured Using Cmax

  4 days

Study Arms (3)

Open Label - BCT197 Part A

EXPERIMENTAL

10mg single dose of BCT197

Drug: BCT197 Part A

BCT197 Part B

EXPERIMENTAL

Single dose of 50mg BCT197

Drug: BCT197 Part B

BCT 197 Placebo Part B

PLACEBO COMPARATOR

Single dose of matching placebo to 50mg BCT197

Drug: Placebo

Interventions

BCT197 Part A DRUG

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

Open Label - BCT197 Part A

Placebo DRUG

Single dose matching placebo administered 2 prior to surgery

BCT 197 Placebo Part B

BCT197 Part B DRUG

BCT197 50mg single dose administered 2 hours prior to surgery

BCT197 Part B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mereo BioPharma: lead
• Novartis: collaborator

Study Sites (13)

Novartis Investigative Site

Orange, California, 92686, United States

Location

Novartis Investigative Site

Saginaw, Michigan, 48601, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68506, United States

Location

Novartis Investigative Site

Cleveland, Ohio, 44195, United States

Location

Novartis Investigative Site

Wynnewood, Pennsylvania, 19096, United States

Location

Novartis Investigative Site

Falls Church, Virginia, 22042, United States

Location

Novartis Investigative Site

Beersheba, 84101, Israel

Location

Novartis Investigative Site

Herzliya, Israel

Location

Novartis Investigative Site

Jerusalem, 91031, Israel

Location

Novartis Investigative Site

Petah Tikva, 49100, Israel

Location

Novartis Investigative Site

Rehovot, 76100, Israel

Location

Novartis Investigative Site

Tel Aviv, 69710, Israel

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

The trial was terminated early after a planned interim analysis due to the lack of benefit of BCT197 in preventing acute kidney injury.

Results Point of Contact

• Title: Dr. Ian Hodgson
• Organization: Mereo BioPharma

enquiries@mereobiopharma.com

+44 333 0237300

Study Officials

• Jacqueline Parkin, PhD FRCP

  Mereo BioPharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 18, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 6, 2020
• Results First Posted: November 8, 2018

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); IL (6); TW (1)