[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06150742":3,"trial-entities:NCT06150742":185,"trial-summary:NCT06150742":189},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":59,"locations":62,"central_contacts":173,"overall_officials":182,"references":183,"see_also_links":184},"NCT06150742","NYD301","Nafamostat Efficacy in Phase 3 Registrational CRRT Study","A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding","RECRUITING","2025-12","2024-10","2025-10-15","2024-08-15","Talphera, Inc","INDUSTRY",false,"A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients undergoing CRRT who cannot tolerate heparin or are at higher risk for bleeding.","Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.",[19],"Acute Kidney Injury",[21,22],"continuous renal replacement therapy","anticoagulation","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},70,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Niyad (nafamostat mesylate)","Niyad (nafamostat mesylate) lyophilized",[36],"Niyad",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Placebo (0.9% NaCl)","0.9% NaCl",[41],"Placebo",[43],{"measure":44,"description":44,"timeFrame":45},"mean post-filter activated clotting time (ACT)","24 hours",[],"ALL","18 Years","80 Years",{"inclusion":51,"exclusion":54,"raw_text":58},[52,53],"Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours","Patients who cannot tolerate heparin or are at high risk of bleeding",[55,56,57],"Patients weighing less than 50 kg","Patients receiving systemic anticoagulation","Patients with active bleeding","Inclusion Criteria:\n\n* Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours\n* Patients who cannot tolerate heparin or are at high risk of bleeding\n\nExclusion Criteria:\n\n* Patients weighing less than 50 kg\n* Patients receiving systemic anticoagulation\n* Patients with active bleeding",[60,61],"ADULT","OLDER_ADULT",[63,76,88,99,110,121,130,141,152,162],{"facility":64,"status":8,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":73},"University of California Los Angeles","Los Angeles","California","90095","United States",[70],{"name":71,"role":72},"Senior Clinical Research Associate","CONTACT",{"lat":74,"lon":75},34.05223,-118.24368,{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":68,"contacts":82,"geoPoint":85},"AdventHealth","NOT_YET_RECRUITING","Orlando","Florida","32804",[83],{"name":84,"role":72},"Program Manager Study Intake",{"lat":86,"lon":87},28.53834,-81.37924,{"facility":89,"status":8,"city":90,"state":91,"zip":92,"country":68,"contacts":93,"geoPoint":96},"Henry Ford Health","Detroit","Michigan","48202",[94],{"name":95,"role":72},"Clinical Study Coordinator",{"lat":97,"lon":98},42.33143,-83.04575,{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":68,"contacts":104,"geoPoint":107},"University of New Mexico","Albuquerque","New Mexico","87131",[105],{"name":106,"role":72},"Nurse Research Coordinator",{"lat":108,"lon":109},35.08449,-106.65114,{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":68,"contacts":115,"geoPoint":118},"Northwell Health","Great Neck","New York","11021",[116],{"name":117,"role":72},"Clinical Research Coordinator",{"lat":119,"lon":120},40.80066,-73.72846,{"facility":122,"status":8,"city":113,"state":113,"zip":123,"country":68,"contacts":124,"geoPoint":127},"Mount Sinai","10029",[125],{"name":126,"role":72},"Clinical Research Assistant",{"lat":128,"lon":129},40.71427,-74.00597,{"facility":131,"status":8,"city":132,"state":133,"zip":134,"country":68,"contacts":135,"geoPoint":138},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[136],{"name":137,"role":72},"Clinical Research Manager",{"lat":139,"lon":140},39.12711,-84.51439,{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":68,"contacts":146,"geoPoint":149},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15213",[147],{"name":148,"role":72},"Assistant Director, Laboratory Operations",{"lat":150,"lon":151},40.44062,-79.99589,{"facility":153,"status":8,"city":154,"state":155,"zip":156,"country":68,"contacts":157,"geoPoint":159},"Medical University of South Carolina","Charleston","South Carolina","29425",[158],{"name":117,"role":72},{"lat":160,"lon":161},32.77632,-79.93275,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":68,"contacts":167,"geoPoint":170},"Baylor University Medical Center","Dallas","Texas","75246",[168],{"name":169,"role":72},"Research Nurse 1",{"lat":171,"lon":172},32.78306,-96.80667,[174,179],{"name":175,"role":72,"phone":176,"phoneExt":177,"email":178},"Nazneen Patel","647-724-5709","305","nazneen.patel@clinchoice.com",{"name":180,"role":72,"email":181},"Chris Houchins","chris.houchins@clinchoice.com",[],[],[],{"nct_id":4,"conditions":186,"biomarkers":188},[187],"Acute Renal Failure",[],{"nct_id":4,"found":190,"summary":191,"prompt_version":201},true,{"design":192,"status":193,"heading":194,"summary":195,"follow_up":196,"word_count":197,"commitments":198,"compensation":199,"drugs_mentioned":200},"This is a prospective, randomized, placebo-controlled study with a planned enrollment of 70 participants. Participants will receive either Niyad or a placebo.","completed","Nafamostat for Anticoagulation During CRRT in Acute Kidney Injury","This study is looking at how well Niyad (nafamostat mesylate) works to prevent blood clots in the dialysis machine (CRRT circuit) for people with acute kidney injury. This is for patients who cannot use heparin or have a high risk of bleeding. You might be able to join if you are between 18 and 80 years old and need continuous renal replacement therapy (CRRT) or started it within the last 48 hours. You cannot join if you weigh less than 50 kg, are already on blood thinners, or have active bleeding. The study will compare Niyad to a placebo (a salt water solution) to see which is better at preventing clots in the dialysis filter after 24 hours. The current recruitment status is unclear.","The primary endpoint is measured at 24 hours, focusing on post-filter activated clotting time.",124,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]