[{"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:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,76],{"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},"100613595","phase-2-a-study-of-praliciguat-in-participants-with-focal-segmental-glomerulosclerosis-fsgs-100613595",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","2026-08-11",{"date":35,"type":36},"2026-08-13","ACTUAL",{"date":38,"type":36},"2025-12-03",{"date":40,"type":20},"2028-01",{"name":42,"class":43},"Akebia Therapeutics","INDUSTRY",25,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100548300","phase-2-a-phase-2-study-to-evaluate-the-safety-pd-pk-and-clinical-activity-of-adx-097-in-participants-with-igan-ln-or-c3g-100548300","NCT06419205","A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G","A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)","Key Inclusion Criteria:\n\nAll participants\n\n1. Male or female participants aged ≥16 years.\n2. uPCR ≥0.5 g\u002Fg (from the average of 3 first morning voids \\[FMVs\\]).\n3. Screening eGFR ≥30 mL\u002Fmin\u002F1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).\n4. Participants receiving a renin-angiotensin-aldosterone system (RAAS) inhibitor, sodium-glucose cotransporter-2 (SGLT2) inhibitor, sparsentan, or atrasenten must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 8 weeks prior to Study Day 1 and the dose is projected to remain stable until completion of the study.\n\n   Participants with IgAN only\n5. Kidney biopsy-proven diagnosis of IgAN with a kidney biopsy that is obtained within 10 years of Day 1 or within 5 years of Day 1 if the participant is known or suspected of also having diabetic nephropathy.\n\n   Participants with LN only\n6. Clinical diagnosis of systemic lupus erythematosus (SLE)\n7. Kidney biopsy-proven diagnosis of LN with a kidney biopsy that is obtained within 24 weeks of Day 1.\n8. Diagnosis of active focal or diffuse LN class III or IV\n\n   Participants with C3G only\n9. Kidney biopsy-proven diagnosis of C3G, either dense deposit disease (DDD) or complement component 3 glomerulonephritis (C3GN), with a kidney biopsy that is obtained within 52 weeks of Day 1.\n10. Participants receiving mycophenolate mofetil (MMF) (or mycophenolic acid) or prednisone ≥10 mg\u002Fd or equivalent must have been on a stable dose for at least 12 weeks before Day 1 that is projected to remain stable until completion of the study.\n\nKey Exclusion Criteria All participants\n\n1. Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening.\n2. Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion.\n3. Participants with a history of and\u002For presence of anti-factor H antibodies at screening.\n4. Uncontrolled hypertension with mean seated systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg based on the average of 2 measurements obtained at approximately 2-minute intervals after the individual has been sitting for 5 minutes.\n5. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.\n6. History of splenectomy.\n\n   Participants with IgAN only\n7. Secondary forms of IgAN\n8. Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1.\n\n   Participants with LN only\n9. Lymphocyte count below 0.5 × 109\u002FL at screening.\n10. Received any of Cyclophosphamide, Calcineurin inhibitors, IV methylprednisolone, IV immunoglobulin therapy, Belimumab, Obinutuzumab and Rituximab treatments at protocol specified time points.\n\n    Participants with C3G only\n11. Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary.\n12. Received systemic corticosteroid therapy, eculizumab, iptacopan, pegcetacoplan, or any other form of immunosuppressive therapy ≤12 weeks before Day 1, except for MMF (or mycophenolic acid), which is permitted.","16 Years",{"count":54,"type":20},30,[23],"A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)",[58,59,60],"IgA Nephropathy","Lupus Nephritis (LN)","C3 (Complement Component 3) Glomerulopathy",[62,63,64,65,66],"Immunoglobulin A Nephropathy","Lupus Nephritis","Complement Component 3 Glomerulopathy","ADX-097","C3G","2026-08-03",{"date":69,"type":36},"2026-08-04",{"date":71,"type":36},"2026-07-30",{"date":73,"type":20},"2028-02",{"name":42,"class":43},2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"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":86,"type":20},70,[88],"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.",[91],"Healthy Volunteers",[93,94,95,96,97,98,99,100,101,91],"AKB-9090","Single-centre","Single Ascending Dose","Multiple Ascending Dose","First-in-human","Safety","Tolerability","Randomized","Double-blind","2026-04-07",{"date":104,"type":36},"2026-04-13",{"date":106,"type":36},"2026-03-16",{"date":108,"type":20},"2026-12",{"name":42,"class":43},1,""]