[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506826":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":40,"responsibleParty":153,"collaborators":30,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":30,"eligibilityCriteria":161,"healthyVolunteers":157,"sex":162,"minAge":163,"maxAge":30,"enrollmentInfo":164,"targetDuration":30,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":30,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"Arch Biopartners Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LSALT Peptide","EXPERIMENTAL","LSALT peptide 10 mg IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days",[13],"Drug: LSALT Peptide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity, potentially minimizing off-target or other adverse effects. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.",[9],[26],"Metablok",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"0.9% saline solution",[15],null,[32,37],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Richard Muruve","CONTACT","+1 647 428 7031","rm@archbiopartners.com",{"name":38,"role":34,"phone":30,"phoneExt":30,"email":39},"David Luke","dl@archbiopartners.com",[41,60,74,90,101,113,123,133,143],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Cumming School of Medicine & Libin Cardiovascular Centre, University of Calgary","RECRUITING","Calgary","Alberta","T2N 4N1","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-114.08529,51.05011,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":58,"phoneExt":30,"email":59},"Alexander J Gregory","403 944 1539","alex.gregory@albertahealthservices.ca",{"facility":61,"status":43,"city":62,"state":63,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Royal Columbian Hospital","New Westminster","British Columbia","V3L 0A2",{"type":50,"coordinates":66},[67,68],-122.91092,49.20678,{"lat":68,"lon":67},[71],{"name":72,"role":34,"phone":73,"phoneExt":30,"email":30},"Derek Gunning","604-522-6800",{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Unity Health Toronto, St. Michael's Hospital","Toronto","Ontario","M5B 1W8",{"type":50,"coordinates":80},[81,82],-79.39864,43.70643,{"lat":82,"lon":81},[85],{"name":86,"role":34,"phone":87,"phoneExt":88,"email":89},"David Mazer","416 864 6060","5825","david.mazer@unityhealth.to",{"facility":91,"status":43,"city":76,"state":77,"zip":92,"country":47,"countryCode":48,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"University Health Network, Toronto General Hospital","M5G 1L7",{"type":50,"coordinates":94},[81,82],{"lat":82,"lon":81},[97],{"name":98,"role":34,"phone":99,"phoneExt":30,"email":100},"Keyvan Karkouti","416 340 3698","keyvan.karkouti@uhn.ca",{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":30,"cosmosGeoPoint":108,"geoPoint":112,"contacts":30},"Gazi University","COMPLETED","Yenimahalle","Ankara","06560","Turkey (Türkiye)",{"type":50,"coordinates":109},[110,111],32.80147,39.97787,{"lat":111,"lon":110},{"facility":114,"status":103,"city":115,"state":116,"zip":117,"country":107,"countryCode":30,"cosmosGeoPoint":118,"geoPoint":122,"contacts":30},"Kosuyolu High Specialization Training and Research Hospital","Kartal","Istanbul","34865",{"type":50,"coordinates":119},[120,121],29.18861,40.90495,{"lat":121,"lon":120},{"facility":124,"status":103,"city":125,"state":126,"zip":127,"country":107,"countryCode":30,"cosmosGeoPoint":128,"geoPoint":132,"contacts":30},"Erciyes University, Faculty of Medicine - Semiha Kibar Organ Transplant & Dialysis Hospital","Melikgazi","Kayseri","38030",{"type":50,"coordinates":129},[130,131],36.21708,38.72455,{"lat":131,"lon":130},{"facility":134,"status":103,"city":135,"state":136,"zip":137,"country":107,"countryCode":30,"cosmosGeoPoint":138,"geoPoint":142,"contacts":30},"Kocaeli University, Faculty of Medicine Practices and Research Hospital","İzmit","Kocaeli","41001",{"type":50,"coordinates":139},[140,141],29.92928,40.76499,{"lat":141,"lon":140},{"facility":144,"status":103,"city":145,"state":146,"zip":147,"country":107,"countryCode":30,"cosmosGeoPoint":148,"geoPoint":152,"contacts":30},"Sütçü İmam University, Faculty of Medicine","Kahramanmaraş","Onikişubat","46040",{"type":50,"coordinates":149},[150,151],36.92641,37.5847,{"lat":151,"lon":150},{"type":154,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100506826","phase-2-lsalt-peptide-for-prevention-or-attenuation-of-acute-kidney-injury-aki-in-patients-undergoing-on-pump-cardiac-surgery-100506826",false,"NCT05879432","LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery","Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT Peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery","Inclusion Criteria:\n\n1. Male and female ≥ 18 years of age.\n2. Scheduled for a non-emergent coronary and\u002For valve surgery procedure requiring on-pump cardiopulmonary bypass including but not limited to:\n\n   * Coronary artery bypass graft (CABG) alone\n   * CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair\n   * Aortic valve replacement or repair alone, with or without aortic root repair\n   * Mitral, tricuspid, or pulmonic valve replacement or repair alone\n   * Simultaneous replacement of several cardiac valves.\n3. Have the following AKI risk factors:\n\n   * CKD Stage 3 (CKD-EPI eGFR ≥ 30 and \\\u003C 60 mL\u002Fmin\u002F1.73 m2) and ONE or more of the following additional risk factors OR\n   * CKD Stage 2 (CKD-EPI eGFR ≥ 60 and \\\u003C 90 mL\u002Fmin\u002F1.73 m2) and ONE or more of the following additional risk factors:\n\n     * Age ≥ 75 years;\n     * Combined valve \\& coronary artery surgery;\n     * Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive techniques;\n     * Urinary (TIMP-2 x IGFBP7) \\> 0.3\n     * Diabetes mellitus\n     * Hypertension\n     * Hyperlipidemia\n4. Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control throughout the study and for at least 1 day following the end of study and have a negative urine pregnancy test at the Screening visit. 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 protocol. 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.\n5. Patient or Legally Authorized Representative (LAR) is available and willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.\n\nExclusion Criteria:\n\n1. The presence of AKI (KDIGO criteria) at the time of randomization\n2. Off-pump cardiac surgery\n3. Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \\\u003C 28°C (82.4° F)\n4. Severe chronic kidney disease: CKD-eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2) OR requiring dialysis\n5. Imminent or recent surgery for aortic dissection\n6. Surgery to correct a major congenital heart defect (e.g., Tetralogy of Fallot, transposition of the great vessels, single ventricle, or Ebstein's anomaly. Bicuspid aortic valve is not considered a congenital heart defect)\n7. Known history of active cancer which may interfere with interpretation of the results of this study\n8. Known or suspected sepsis at time of screening\n9. Pregnancy or lactation\n10. Known hypersensitivity to the study drug or any of its excipients\n11. Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug and throughout the study\n12. Any disease processes or confounding variables that would inappropriately alter the outcome of the study in the opinion of the investigator\n13. Inability to comply with the requirements of the study protocol.","ALL","18 Years",{"count":165,"type":166},240,"ESTIMATED","INTERVENTIONAL",[169],"PHASE2","To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria:\n\n1. Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol\u002FL (≥0.3 mg\u002FdL) within 7 days; OR\n2. Increase in baseline SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the first 7 days following surgery; OR\n3. Urine output \\\u003C 0.5 mL\u002Fkg\u002Fh for \\>6 hours.",[172,173],"Acute Kidney Injury","Cardiac Surgery","2026-06-10",{"date":176,"type":177},"2026-06-12","ACTUAL",{"date":179,"type":177},"2024-03-08",{"date":181,"type":166},"2027-08",{"name":5,"class":6},9]