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.
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…
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