Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy
ConditionIgAN
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSitala Bio LTD
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Secondary IgAN or unclear exclusion of secondary causes.
Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk).
Other systemic diseases causing proteinuria/CKD or severe urinary obstruction.
Known or suspected immunodeficiency or hereditary complement deficiency.
Trial design
Treatments tested in this trial
- STL303
- STL303
- Placebo capsule
Treatment groups
15 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov