A Trial of HRS-5965 Capsule in Primary IgA Nephropathy
ConditionPrimary IgA Nephropathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Suncadia Medicine Co., Ltd.
About this trial
This multicenter, randomized, double-blind, parallel, placebo-controlled study is being conducted to evaluate the efficacy, and safety of HRS-5965 capsule for primary IgA nephropathy.
Eligibility criteria
Qualifiers
Able and willing to provide a written informed consent；
Weight ≥35 kg, Body mass index (BMI) < 37.5kg /m2;
Primary IgA nephropathy was confirmed by renal biopsy within 8 years;
24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomization;
Disqualifiers
Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
Patients with secondary IgA nephropathy as determined by the investigator;
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 a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic Syndrome;
Trial design
Treatments tested in this trial
- HRS-5965
- Placebo
Treatment groups
378 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov