Actively Recruiting
Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2024-11-01
80
Participants Needed
2
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
CONDITIONS
Official Title
Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study requirements
- Male or female patients aged 18 years or older
- Weight at least 35 kg and body mass index below 35 kg/m2
- Biopsy-confirmed diagnosis of IgA nephropathy within the last five years
- Urine protein level of at least 0.75 g/24hr or urine protein to creatinine ratio of at least 0.8 g/g at screening
- Glomerular Filtration Rate (GFR) of 30 mL/min per 1.73 m2 or higher
You will not qualify if you...
- Use of other investigational drugs within 5 half-lives or 90 days before enrollment
- History of any organ transplant, including bone marrow
- History of cancer in the past 5 years, except certain skin or cervical cancers
- Medical conditions that may affect drug processing or increase risk during the study
- Pregnant or breastfeeding women
- Plasma donation of 400 mL or more within 12 weeks before first dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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