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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
NTQ5082 capsules 100 mg
NTQ5082 capsules 200 mg
NTQ5082 capsules 300 mg
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline after 12 weeks of treatment.
Time frame: Week 12
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline during treatment period except week 12
Time frame: From week 1 to week 24
The change in estimated glomerular filtration rate(eGFR) compared to baseline during treatment period.
Time frame: From week 1 to week 24
The change in serum creatinine (SCr) compared to baseline during treatment period.
Time frame: From week 1 to week 24
The log-transformed ratios of first morning void (FMV) UPCR and UACR compared to baseline during treatment period
Time frame: From week 1 to week 24
The change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale score compared to baseline during the treatment period.
0-52,the higher the score, the better the QOL.
Time frame: From week 1 to week 24
Incidence and severity of adverse events [safety and tolerability]
Adverse events were based on clinically significant laboratory tests, vital signs, physical examination, and 12-lead electrocardiography
Time frame: 28weeks
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Placebo