Safety and helpful dose test of STL303 in adults with IgA nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb trial enrolling about 15 adults with primary IgA nephropathy. Participants will receive STL303 at two dose levels or placebo once daily, in a 1:1:1 ratio, while on stable background therapy. The study aims to evaluate whether STL303 improves kidney outcomes and to identify an optimal dose with acceptable safety. Efficacy and safety will be assessed through regular monitoring and predefined endpoints. The trial is sponsored by Sitala Bio Ltd and conducted at three hospitals in New South Wales, Australia.

Why it matters

Who can join: the full rules

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.

Where it's running

• John Hunter Hospital
  Newcastle, New South Wales, Australia Recruiting
• Nepean Hospital
  Penrith, New South Wales, Australia Recruiting
• Concord Hospital
  Sydney, New South Wales, Australia Recruiting
• Research Site
  Woolloongabba, Queensland, Australia Recruiting
• Research Site
  Clayton, Victoria, Australia Recruiting
• Research Site
  Saint Albans, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Eugenia Pedagogos — Western Health (Sunshine Hospital)
• Study coordinator: Clinical Operations Manager
• Email: studies@sitala.com
• Phone: +61 421 585707

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.