A Trial of HRS-5965 Capsule in Primary IgA Nephropathy

Recruiting Phase 3 Interventional Study
Primary IgA Nephropathy
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
378 (estimated)
Sponsor
Chengdu Suncadia Medicine Co., Ltd. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide a written informed consent; 2. Weight ≥35 kg, Body mass index (BMI) \< 37.5kg /m2; 3. Primary IgA nephropathy was confirmed by renal biopsy within 8 years; 4. 24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomizati…
Contacts

Sheng Qi

+86 0518 82342973

Sheng.qi@hengrui.com

CONTACT