Efficacy and Safety Study of HS-10542 for IgA Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
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.);
Trial design
Treatments tested in this trial
- HS-10542 High Dose
- HS-10542 Low Dose
- Placebo
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov