[{"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:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,58],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":18,"type":19},60,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25],"Focal Segmental Glomerulosclerosis",[27,28,29,30],"Glomerular Disease","Chronic Kidney Disease","Proteinuria","Urine protein-to-creatinine ratio","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2025-12-03",{"date":39,"type":19},"2028-01",{"name":41,"class":42},"Akebia Therapeutics","INDUSTRY",23,{"id":45,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":23,"conditions":49,"keywords":50,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":55,"leadSponsor":56,"locationsCount":57},"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":18,"type":19},[22],[25],[27,28,29,30],"2026-06-03",{"date":53,"type":35},"2026-06-05",{"date":37,"type":35},{"date":39,"type":19},{"name":41,"class":42},14,{"id":59,"slug":4,"hasResults":10,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":15,"minAge":16,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":20,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"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":67,"type":19},70,[69],"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.",[72],"Healthy Volunteers",[74,75,76,77,78,79,80,81,82,72],"AKB-9090","Single-centre","Single Ascending Dose","Multiple Ascending Dose","First-in-human","Safety","Tolerability","Randomized","Double-blind","2026-04-07",{"date":85,"type":35},"2026-04-13",{"date":87,"type":35},"2026-03-16",{"date":89,"type":19},"2026-12",{"name":41,"class":42},1,""]