Testing LSALT Peptide against a placebo for acute kidney injury

Inclusion

• +Age ≥ 75 years;
• +CKD Stage 3 (CKD-EPI eGFR ≥ 30 and \< 60 mL/min/1.73 m2) and ONE or more of the following additional risk factors OR
• +CKD Stage 2 (CKD-EPI eGFR ≥ 60 and \< 90 mL/min/1.73 m2) and ONE or more of the following additional risk factors:
• +Male and female ≥ 18 years of age.
• +Coronary artery bypass graft (CABG) alone
• +CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
• +Aortic valve replacement or repair alone, with or without aortic root repair
• +Mitral, tricuspid, or pulmonic valve replacement or repair alone
• +Simultaneous replacement of several cardiac valves.
• +Have the following AKI risk factors:
• +Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive techniques;
• +Urinary (TIMP-2 x IGFBP7) \> 0.3
• +Diabetes mellitus
• +Hypertension
• +Hyperlipidemia
• +Patient or Legally Authorized Representative (LAR) is available and willing to give written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.
• +Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth controlControl groupThe group a new treatment is measured against.Read more → throughout the study and for at least 1 day following the end of study and have a negative urine pregnancy test at the Screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →. A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or the implant. In patients who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocolProtocolThe detailed plan a study must follow.Read more →. Women who are of nonchild-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women and nursing mothers are excluded from this study.
• +Scheduled for a non-emergent coronary and/or valve surgery procedure requiring on-pump cardiopulmonary bypass including but not limited to:
• +Combined valve \& coronary artery surgery;