AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy

RecruitingPhase 2Ages 18 Years - anyAllSitala Bio LTD
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy: 2. 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. 3. UPCR greater than or equal to 0.75 g/g at screening and after completion of run-in. 4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose. 5. 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. 6. 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 Criteria: 1. Secondary IgAN or unclear exclusion of secondary causes. 2. Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk). 3. Other systemic diseases causing proteinuria/CKD or severe urinary obstruction. 4. Known or suspected immunodeficiency or hereditary complement deficiency. 5. Any organ transplant recipients except corneal. 6. Poorly controlled blood pressure (SBP greater than 150 or DBP great than 90). 7. Use of immunosuppressive drugs within 90 days or 5 half-lives. 8. Prior oral budesonide (Nefecon/Tarpeyo/Kinpeygo) within 6 months. 9. Prior complement inhibitors within 30 days, 5 half-lives, or residual effect period. 10. Major systemic diseases preventing participation (e.g., NYHA IV, severe pulmonary disease). 11. Significantly abnormal liver function (greater than 3× ULN enzymes or greater than 2× ULN bilirubin). 12. QTcF greater than 500 ms. 13. History of malignancy within 5 years (exceptions apply). 14. History of meningococcal, pneumococcal, or Hib infection. 15. Chronic/recurrent infections in past year (e.g., liver abscess, pyelonephritis). 16. Active systemic infections within 2 weeks or fever greater than 38°C within 7 days.
💊

What it tests

  • STL303
  • STL303
  • Placebo capsule
📍

Where

8 sites
John Hunter Hospital
Newcastle, Australia
Nepean Hospital
Penrith, Australia
Prince of Wales Hospital
Sydney, Australia
Concord Hospital
Sydney, Australia
Research Site
Woolloongabba, Australia
Research Site
Clayton, Australia
Research Site
Saint Albans, Australia
Royal Perth Hospital
Perth, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy