[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639148":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":79,"collaborators":30,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":30,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":30,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":100,"whyStopped":30,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Sitala Bio LTD","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"STL303 dose level 1","EXPERIMENTAL","Participants will receive STL303 dose level 1",[13],"Drug: STL303",{"label":15,"type":10,"description":16,"interventionNames":17},"STL303 Dose Level 2","Participants will receive STL303 dose level 2",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo",[23],"Drug: Placebo capsule",[25,31,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","STL303","STL303 arm participants will receive a specific dose of STL303",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":32,"otherNames":30},[15],{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":30},"Placebo capsule","Placebo arm participants will receive placebo capsules",[19],[38],{"name":39,"affiliation":40,"role":41},"Eugenia Pedagogos","Western Health (Sunshine Hospital)","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Clinical Operations Manager","CONTACT","+61 421 585707","studies@sitala.com",[49,62,71],{"facility":50,"status":30,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":30},"Research Site","Woolloongabba","Queensland","4102","Australia","AU",{"type":57,"coordinates":58},"Point",[59,60],153.03655,-27.48855,{"lat":60,"lon":59},{"facility":50,"status":30,"city":63,"state":64,"zip":65,"country":54,"countryCode":55,"cosmosGeoPoint":66,"geoPoint":70,"contacts":30},"Clayton","Victoria","3168",{"type":57,"coordinates":67},[68,69],145.11667,-37.91667,{"lat":69,"lon":68},{"facility":50,"status":30,"city":72,"state":64,"zip":73,"country":54,"countryCode":55,"cosmosGeoPoint":74,"geoPoint":78,"contacts":30},"Saint Albans","3021",{"type":57,"coordinates":75},[76,77],144.8,-37.73333,{"lat":77,"lon":76},{"type":80,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100639148","phase-2-safety-and-efficacy-of-stl303-in-patients-with-primary-immunoglobulin-a-iga-nephropathy-100639148",false,"NCT07606352","Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy","A Multicenter, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy","Inclusion Criteria:\n\n1. Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy:\n2. eGFR (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) greater than or equal to 30 mL\u002Fmin\u002F1.73 m2 at screening and after completion of run-in.\n3. UPCR greater than or equal to 0.75 g\u002Fg at screening and after completion of run-in.\n4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose.\n5. Have received stable treatment with RASis (ACEi or ARB) at the maximum recommended dose or MTD for at least 90 days prior to the first dose.\n6. If the patient has been treated with SGLT2i, diuretics, other antihypertensive treatments, ERA, and\u002For hydroxychloroquine for IgAN prior to the first dose, the drug should also be used stably for at least 90 days.\n\nExclusion Criteria:\n\n1. Secondary IgAN or unclear exclusion of secondary causes.\n2. Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk).\n3. Other systemic diseases causing proteinuria\u002FCKD or severe urinary obstruction.\n4. Known or suspected immunodeficiency or hereditary complement deficiency.\n5. Any organ transplant recipients except corneal.\n6. Poorly controlled blood pressure (SBP greater than 150 or DBP great than 90).\n7. Use of immunosuppressive drugs within 90 days or 5 half-lives.\n8. Prior oral budesonide (Nefecon\u002FTarpeyo\u002FKinpeygo) within 6 months.\n9. Prior complement inhibitors within 30 days, 5 half-lives, or residual effect period.\n10. Major systemic diseases preventing participation (e.g., NYHA IV, severe pulmonary disease).\n11. Significantly abnormal liver function (greater than 3× ULN enzymes or greater than 2× ULN bilirubin).\n12. QTcF greater than 500 ms.\n13. History of malignancy within 5 years (exceptions apply).\n14. History of meningococcal, pneumococcal, or Hib infection.\n15. Chronic\u002Frecurrent infections in past year (e.g., liver abscess, pyelonephritis).\n16. Active systemic infections within 2 weeks or fever greater than 38°C within 7 days.","ALL","18 Years",{"count":91,"type":92},15,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of STL303 capsules in IgAN patients. About 15 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of STL303 or placebo capsules orally according to protocol.",[98],"IgAN",[98],"NOT_YET_RECRUITING","2026-05-24",{"date":103,"type":104},"2026-05-28","ACTUAL",{"date":106,"type":92},"2026-06",{"date":108,"type":92},"2027-09",{"name":5,"class":6},3]