Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy
ConditionIgAN
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
STL303
DrugSTL303 arm participants will receive a specific dose of STL303
STL303
DrugSTL303 arm participants will receive a specific dose of STL303
Placebo capsule
DrugPlacebo arm participants will receive placebo capsules
Treatment groups
15 Participants
are divided into 3 treatment groupsGroup A: STL303 dose level 1Experimental treatment 1 intervention
Group B: STL303 Dose Level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment emergent adverse events (TEAEs), adverse events (AEs) and serious adverse events (SAEs)
All participants will be observed for any AE during the clinical study, including abnormalities in clinical symptoms and vital signs, physical examination, laboratory tests, and 12-lead ECG. Incidence, severity, and relationship of TEAEs and serious adverse events (SAEs) to STL303. Possible adverse events include: palpitations, nausea, vomiting, dizziness, sore throat, upper respiratory infection, loss of appetite, high temperature, chest discomfort, weakness, rash, headache, lethargy (feeling tired and low on energy) and urinary tract infection.
Time frame
Adverse events will be closely monitored, and participants will report to the clinic on Days 7, 14, 30, 45, 60, 90, 135 and at end of treatment on Day 180. On Day 210 an End of study safety follow up will also be conducted.Secondary outcomes
1
Change from baseline urine protein-to-creatinine ratio (UPCR)
Change in baseline 24-hour urine collection
Time frame
24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 1802
Change in UPCR
Change in baseline 24-hour urine collection
Time frame
24-hour urine collection pre-dose on Days 1 (baseline), 30, 60 and 903
Change in urine albumin-to-creatinine ratio (UACR)
Change in baseline 24-hour urine collection
Time frame
24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 1804
Change in blood creatinine level
Peripheral blood sampling
Time frame
Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180Sponsors and contacts
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Source ClinicalTrials.gov