Actively Recruiting
A Trial of HRS-5965 Capsule in Primary IgA Nephropathy
Led by Chengdu Suncadia Medicine Co., Ltd. · Updated on 2025-08-05
378
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of HRS-5965 Capsule in Primary IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Weight of at least 35 kg and body mass index (BMI) less than 37.5 kg/m2
- Primary IgA nephropathy confirmed by kidney biopsy within 8 years
- 24-hour urinary protein excretion of at least 1.0 g or 24-hour urine protein to creatinine ratio of at least 0.8 g/g at screening and prior to randomization
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73m2 or higher at screening and prior to randomization
- Fertile female participants or males with fertile female partners who agree to use effective contraception from consent until one month after last dose
- Understanding of study procedures and voluntary agreement to participate by signing informed consent
- Receiving stable optimal supportive therapy including RAS blockers at maximum tolerated or recommended dose for at least 12 weeks before randomization
You will not qualify if you...
- Allergy to any RAS blockers, investigational products, or their components
- Secondary IgA nephropathy diagnosed by the investigator
- Rapid decline in kidney function or kidney pathology showing over 50% large crescent formation or tubule atrophy with interstitial fibrosis over 50%
- History of immunodeficiency or other systemic diseases likely causing proteinuria or nephrotic syndrome
- History of any organ transplant
- Active infections such as tuberculosis within 1 year or infections requiring intravenous antibiotics within 2 weeks prior to randomization
- History of malignant tumors
- Severe trauma or major surgery within 12 weeks before screening or planned surgery during the study
- History of significant blood loss (400 mL or more) or blood transfusion within 12 weeks prior to screening
- Diseases or conditions that may affect drug absorption, metabolism, or excretion
- Disease progression or recovery as determined by the investigator
- Elevated liver enzymes or bilirubin exceeding three times the upper limit of normal at screening
- Participation in another clinical trial or use of investigational drugs or devices within 12 weeks before randomization
- Pregnant or breastfeeding women
- History of drug abuse
- Use of systemic glucocorticoids or immunosuppressants within 12 weeks prior to randomization
- Use of biologics or cytokine inhibitors within 6 months prior to randomization
- Any physical or mental condition that increases study risk or may affect adherence or completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
S
Sheng Qi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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