Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study.
- Participants must be able to communicate well with the investigator and to understand
and comply with the requirements of the study.
- Male and female patients ≥ 45 years at screening.
- Participants must weigh at least 50 kg and maximum 150 kg to participate in the study
and must have a body mass index (BMI) below 40. BMI = Body weight (kg) / [Height
(m)]2.
- At screening, vital signs (systolic and diastolic blood pressure and pulse rate) will
be assessed in the sitting position. Sitting vital signs should be within the
following ranges:
1. oral body temperature between 35.0-37.5 °C
2. blood pressure (systolic 100-160 mmHg, diastolic < 100 mmHg)
3. pulse rate (50-100/min) stable with or without medication(s) as per Investigator
assessment.
- No known increase in SCr of ≥25% at screening visit compared to a previous value not
older than 6 weeks as documented by a local laboratory using standard assay
methodology.
- Non-emergent open chest cavity major cardiopulmonary bypass (CPB) surgery with
expected CPB time ≥ 1 hour
Exclusion Criteria:
- eGFR at screening < 15 mL/min/1.73 m^2 (calculated using CKD-EPI 2021 equation).
- Currently receiving renal replacement therapy.
- Patients with bleeding risk at screening. The Investigator should make this
determination in consideration of the participant's medical history and/or clinical or
laboratory evidence of any of the following:
- History of bleeding with suspected or confirmed bleeding disorder or any other
high risk for bleeding in the opinion of the investigator
- Thrombocytopenia: platelet count< 100 x10^9/L
- Platelet dysfunction; e.g., ADP induced platelet aggregation lower than 60 %
- Pre-existing coagulation factor deficiency: including, but not limited to.
fibrinogen < 2.5-2.8 g/L
- Any emergency surgeries performed less than 30 days before screening, including aortic
dissection, and/or major congenital heart defects.
- Scheduled to undergo cardiac surgery off CPB or with hypothermic circulatory arrest.
- Cardiogenic shock or hemodynamic instability within four weeks prior to surgery,
requiring inotropes or vasopressors or mechanical devices such as intra-aortic balloon
counter-pulsation (IABP).
- Have received cardiopulmonary resuscitation (CPR) within 30 days prior to cardiac
surgery.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives
of enrollment, or until the expected PD effect has returned to baseline, whichever is
longer; or longer if required by local regulations.
- Patients who are post-nephrectomy
- Have ongoing sepsis or history of sepsis within the past 8 weeks or untreated
diagnosed infection prior to screening visit. Sepsis is defined as presence of a
confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension.
- Recent (within the last three years) and/or recurrent history of autonomic dysfunction
(e.g., recurrent episodes of fainting, palpitations, etc.).
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
while taking study treatment and until the end of study. Highly effective
contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of
the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal,
post-ovulation methods) and withdrawal are not acceptable methods of
contraception.
- Female bilateral tubal ligation, female sterilization (have had surgical
bilateral oophorectomy with or without hysterectomy) or total hysterectomy at
least six weeks before taking study treatment. In case of oophorectomy alone,
only when the reproductive status of the woman has been confirmed by follow up
hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female
participants on the study, the vasectomized male partner should be the sole
partner for that participant.
- Use of oral (estrogen and progesterone), injected, or implanted hormonal methods
of contraception or placement of an intrauterine device (IUD) or intrauterine
system (IUS), or other forms of hormonal contraception that have comparable
efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal
hormone contraception.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 4/10/23. Questions regarding updates should be directed to the study team contact.