Efficacy and Safety Study of HS-10542 for IgA Nephropathy (NCT07474636) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety Study of HS-10542 for IgA Nephropathy
China90 participantsStarted 2026-03-17
Plain-language summary
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.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent.
✓. Body weight≥35kg, BMI\<37.5kg/m2.
✓. Primary IgA nephropathy was confirmed by renal biopsy within 8 years.
✓. 24-hour urine protein excretion≥1.0g/24h, or UPCR≥0.8g/g at screening and prior to randomization.
✓. eGFR≥30 ml/min/1.73m2 at screening and prior to randomization；
✓. A fertile female participant or a male participant whose partner is a fertile female, who has not had a fertility, sperm/egg donation plan and voluntarily takes highly effective contraceptive measures (including the partner).
✓. All participants received RAS blocker treatment at least for 12 weeks, or demonstrated intolerance to RAS blockers, but has received SGLT2 inhibitors, endothelin receptor antagonists, or a mineralocorticoid receptor antagonist for at least 12 weeks, and have achieved the maximum recommended dose according to the product label or the maximum tolerated dose with stable dosing for at least 4 weeks prior to randomization.
✓. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.
Exclusion criteria
✕. Participants with a history of severe allergies to drugs, food or the environment, or allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
What they're measuring
1
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection)
. Participant has secondary forms of IgAN as defined by investigator (eg, IgA vasculitis nephritis, SLE) or participant has nephrotic syndrome (defined as proteinuria\>3.5 g/day and serum albumin\<3.0 g/dL, with or without edema);
✕. IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
✕. Patients with concomitant immunodeficiency disorders; or those with other systemic diseases assessed by the investigator as potentially causing proteinuria (e.g., diabetic nephropathy, autoimmune diseases, ANCA-associated vasculitis, etc.);
✕. Any organ transplant recipient, including those who have undergone solid organ transplants, bone marrow transplants and haematopoietic stem cell transplants.
✕. Participants with a medical history of invasive infections caused by capsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae;
✕. Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess and pyelonephritis; Or participants with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;
✕. Participants have a history of malignancy (except of radical excision of basal cell or squamous cell skin cancer, or cervical carcinoma in situ.), Participants with prior malignancy who have been documented to be cancer-free for≥5 years may be enrolled;