[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Akebia Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053231","phase-2-a-study-of-praliciguat-in-participants-with-focal-segmental-glomerulosclerosis-fsgs-100053231",false,"NCT07268638","A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)","A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Praliciguat in Patients With Biopsy-Confirmed Focal Segmental Glomerulosclerosis","Inclusion Criteria:\n\n1. UPCR ≥1 (g\u002Fg) during screening.\n2. On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.\n3. Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n4. Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS.\n\nExclusion Criteria:\n\n1. Collapsing FSGS in the kidney biopsy report.\n2. Sickle cell disease.\n3. HbA1c \\>8%.\n4. Uncontrolled hypertension (≥160\u002F100 millimeters of mercury).","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). Participants will be randomized 1:1 to receive praliciguat or placebo for initial 24 week treatment period. Following this double-blind period, all participants will receive praliciguat in an open-label extension for an additional 24 weeks.",[26],"Focal Segmental Glomerulosclerosis",[28,29,30,31],"Glomerular Disease","Chronic Kidney Disease","Proteinuria","Urine protein-to-creatinine ratio","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2025-12-03",{"date":40,"type":20},"2028-01",{"name":42,"class":43},"Akebia Therapeutics","INDUSTRY",23,{"id":46,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":24,"conditions":50,"keywords":51,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":56,"leadSponsor":57,"locationsCount":58},"100613595","Inclusion Criteria:\n\n1. UPCR ≥1 (g\u002Fg) during screening.\n2. On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.\n3. Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n4. Kidney biopsy within 3 years of screening consistent with FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.\n\nExclusion Criteria:\n\n1. Collapsing FSGS in the kidney biopsy report.\n2. Sickle cell disease.\n3. HbA1c \\>8% or non-fasting blood glucose \\>180 milligram\u002Fdecilitre.\n4. Uncontrolled hypertension (≥160\u002F100 millimeters of mercury)",{"count":19,"type":20},[23],[26],[28,29,30,31],"2026-06-03",{"date":54,"type":36},"2026-06-05",{"date":38,"type":36},{"date":40,"type":20},{"name":42,"class":43},14,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100625928","phase-1-sad-and-mad-study-of-akb-9090-in-healthy-adult-participants-100625928","NCT07429006","SAD and MAD Study of AKB-9090 in Healthy Adult Participants","A Randomized, Double-Blind, Placebo-Controlled, Single (SAD) and Multiple Ascending-Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AKB-9090 Administered Intravenously to Healthy Adult Participants","Key Inclusion Criteria:\n\n* Healthy adult participants with no clinically significant findings, as judged by the investigator, based on physical examination, 12-lead ECG, alcohol breath test, and clinical laboratory tests (including serum chemistry, hematology, coagulation, urine drug screen, and urinalysis).\n* Body mass index (BMI) greater than 18.5 and less than 32.0 kg\u002Fm\\^2 at screening.\n* In the Investigator's opinion, willing and able to provide written informed consent and comply with the all protocol requirements, including required confinement, outpatient visits, and protocol-specified restrictions (including refraining from major lifestyle changes) from signature of the informed consent form (ICF) through the last study visit.\n\nKey Exclusion Criteria:\n\n* Clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatologic, urogenital, ophthalmologic, ear\u002Fnose\u002Fthroat, psychiatric, or neurologic disorder.\n* History of active or recurrent malignancy within 2 years before screening or during the screening period, or currently receiving treatment or suppressive therapy for cancer, except for:\n\n  1. Treated basal cell carcinoma of the skin\n  2. Curatively resected squamous cell carcinoma of the skin\n  3. Treated colonic or cervical carcinoma in situ\n* Abnormal ECG findings at screening, including:\n\n  1. Severe bradycardia (heart rate \\\u003C40 beats per minute) on any measurement\n  2. Mean QT Interval Using Fridericia's Formula (QTcF) \\>450 msec for males or \\>470 msec for females\n* Elevated laboratory values (\\>1.25 × upper limit of normal \\[ULN\\]) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine at the screening visit or at check-in.\n* Evidence of acute or chronic hepatitis B (positive hepatitis B surface antigen) or hepatitis C infection (positive hepatitis C antibody and positive hepatitis C ribonucleic acid \\[RNA\\] test).\n* Use of nicotine-containing products (including cigarettes, cigars, tobacco, gum, patches, vaping, and e-cigarettes), caffeine-containing foods or beverages, and alcohol-containing foods or beverages during study.",true,"60 Years",{"count":69,"type":20},70,[71],"PHASE1","This is a first-in-human (FIH study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic effects of AKB-9090 in healthy adult participants. The study consists of two stages: Stage 1, a single ascending dose (SAD) phase with five dose cohorts, and Stage 2, a multiple ascending dose (MAD) phase with three dose cohorts. Approximately 40 participants in SAD and 30 in MAD are planned to be enrolled.",[74],"Healthy Volunteers",[76,77,78,79,80,81,82,83,84,74],"AKB-9090","Single-centre","Single Ascending Dose","Multiple Ascending Dose","First-in-human","Safety","Tolerability","Randomized","Double-blind","2026-04-07",{"date":87,"type":36},"2026-04-13",{"date":89,"type":36},"2026-03-16",{"date":91,"type":20},"2026-12",{"name":42,"class":43},1,""]