This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.
This is a Phase 2, randomized, double-blind, parallel, placebo-controlled study in patients aged 18 years or above with biopsy confirmed diagnosis of IgA nephropathy. The clinical trial is designed to test the effectiveness and safety of multiple doses of HS-10542. The main objectives is to evaluate the dose response of different doses of HS-10542 by measuring urine protein-to-creatinine ratio (UPCR). The trial is comprised of three main periods, Screening, Treatment (24 weeks) and Follow-Up (4 weeks). Approximately 90 patients will be enrolled. The findings from this study will form the basis for subsequent clinical development of HS-10542.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Peking University First Hospital
Beijing, Beijing Municipality, China
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection)
The change of UPCR from baseline
Time frame: Baseline and Week 12
Incidence and severity of adverse events of HS-10542 at each dosing
Time frame: Baseline to End of Study (week 24)
Changes from baseline in blood pressures
Blood pressure measured during vital sign assessments
Time frame: Baseline to End of Study (week 24)
Changes from baseline in heart rate
Heart rate measured during vital sign assessments
Time frame: Baseline to End of Study (week 24)
Changes from baseline in body temperature
Body temperature measured during vital sign assessments.
Time frame: Baseline to End of Study (week 24)
Changes from baseline in electrocardiogram (ECG) intervals
ECG intervals, and overall assessment will be recorded, includeing heart rate, PR, QRS, and QT(QTcF) intervals. QTcF will be calculated using Fridericia's formula: QTcF=QT/(RR⁰·³³), where RR is the standardized heart rate value derived as 60 / heart rate.
Time frame: Baseline to End of Study (week 24)
Change from baseline in white blood cell count
Time frame: Baseline to End of Study (week 24)
Change from baseline in hemoglobin
Time frame: Baseline to End of Study (week 24)
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Change from baseline in platelet count
Time frame: Baseline to End of Study (week 24)
Change from baseline in alanine aminotransferase
Time frame: Baseline to End of Study (week 24)
Change from baseline in aspartate aminotransferase
Time frame: Baseline to End of Study (week 24)
Change from baseline in total bilirubin
Time frame: Baseline to End of Study (week 24)
Change from baseline in serum creatinine
Time frame: Baseline to End of Study (week 24)
Change from baseline in urinary erythrocyte count
Urinary erythrocyte count assessed by microscopic examination of urine sediment
Time frame: Baseline to End of Study (week 24)
Change from baseline in prothrombin time
Time frame: Baseline to End of Study (week 24)
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection)
The change of UPCR from baseline
Time frame: Baseline and week 24
Change from baseline in estimated Glomerular Filtration Rate(eGFR)
Change from baseline in eGFR at treatment
Time frame: Baseline to End of Study (week 24)
Change from baseline in activated partial thromboplastin time
Time frame: Baseline to End of Study (week 24)