Tests STL303 capsules in adults with IgA nephropathy, a kidney disease
Tests STL303 capsules against placebo in adults with IgA nephropathy.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy
Key facts
- Where
- Clayton, Newcastle, Penrith, Perth, Saint Albans, Sydney, and Woolloongabba, AustraliaSee the 8 sites
- Phase
- Phase 2
Where in Australia
- ClaytonClayton, AustraliaTaking people
- John Hunter HospitalNewcastle, AustraliaTaking people
- Nepean HospitalPenrith, AustraliaTaking people
- Royal Perth HospitalPerth, AustraliaNot yet recruiting
- Saint AlbansSaint Albans, AustraliaTaking people
- Concord HospitalSydney, AustraliaTaking people
- Prince of Wales HospitalSydney, AustraliaNot yet recruiting
- WoolloongabbaWoolloongabba, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sitala Bio LTD
- Trial code
- NCT07606352
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy
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.
Inclusion: Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy:; eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) greater than or equal to 30 mL/min/1.73 m2 at screening and after completion of run-in; UPCR greater than or equal to 0.75 g/g at screening and after completion of run-in; Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose; 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; If the patient has been treated with SGLT2i, diuretics, other antihypertensive treatments, ERA, and/or hydroxychloroquine for IgAN prior to the first dose, the drug should also be used stably for at least 90 days.
Exclusion: Any organ transplant recipients except corneal; Use of immunosuppressive drugs within 90 days or 5 half-lives; Prior oral budesonide (Nefecon/Tarpeyo/Kinpeygo) within 6 months; Prior complement inhibitors within 30 days, 5 half-lives, or residual effect period; Other systemic diseases causing proteinuria/CKD or severe urinary obstruction; Major systemic diseases preventing participation (e.g., NYHA IV, severe pulmonary disease); History of malignancy within 5 years (exceptions apply); History of meningococcal, pneumococcal, or Hib infection; Chronic/recurrent infections in past year (e.g., liver abscess, pyelonephritis); Active systemic infections within 2 weeks or fever greater than 38°C within 7 days; Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk); Significantly abnormal liver function (greater than 3× ULN enzymes or greater than 2× ULN bilirubin); Secondary IgAN or unclear exclusion of secondary causes; Known or suspected immunodeficiency or hereditary complement deficiency; Poorly controlled blood pressure (SBP greater than 150 or DBP great than 90); QTcF greater than 500 ms.