NTQ5082 is a small molecule inhibitor of complement factor B (CFB) that inhibits the enzymatic activity of CFB, thereby blocking the alternative pathway of the complement activation cascade. It is being clinically developed for the treatment of primary IgA nephropathy The main objectives of the study were to assess the efficacy and safety of NTQ5082 capsules in the treatment of patients with primary IgA nephropathy.
Age ≥18 years, male or female.
Body weight ≥40 kg, BMI between 15 to 38 kg/m².
Diagnosis of primary IgA nephropathy confirmed by renal biopsy within 8 years before screening or during screening.
24-hour urine protein excretion (24h-UPE) ≥0.75 g/24h, or first morning void (FMV) urine protein-to-creatinine ratio (UPCR) ≥0.8 g/g.
Receipt of aldosterone receptor antagonists, renin inhibitors, or medications significantly affecting creatinine levels within 4 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
Continuous use of systemic corticosteroids, immunosuppressants/modulators, or Chinese herbal medicines with immunosuppressive effects within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
Treatment with biological agents or complement pathway inhibitors (other than the study drug) within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
History of gastrointestinal surgery potentially altering drug absorption/distribution/metabolism/excretion, severe gastrointestinal disorders, or conditions causing dysphagia/recurrent vomiting that may interfere with oral medication intake.
Parallel
NTQ5082 capsules 100 mg
DrugNTQ5082 capsules 100 mg
NTQ5082 capsules 200 mg
DrugNTQ5082 capsules 200 mg
NTQ5082 capsules 300 mg
DrugNTQ5082 capsules 300 mg
Placebo
DrugPlacebo
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline after 12 weeks of treatment.
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline during treatment period except week 12
The change in estimated glomerular filtration rate(eGFR) compared to baseline during treatment period.
The change in serum creatinine (SCr) compared to baseline during treatment period.
The log-transformed ratios of first morning void (FMV) UPCR and UACR compared to baseline during treatment period
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