Actively Recruiting
A Multicenter, Open-Label Phase II Clinical Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in the Treatment of Primary IgA Nephropathy
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-06-01
73
Participants Needed
2
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and efficacy of HSK39297 tablets in people with primary IgA nephropathy who have completed a previous related study. This Phase II, multicenter, open-label trial focuses on patients with a stable condition and a favorable benefit-risk profile for HSK39297 treatment. The study aims to assess treatment effects over 48 weeks and includes careful monitoring of adverse events and kidney function markers. Participants will start taking HSK39297 at a dose of 200 mg once daily. After 8 to 12 weeks on this stable dose, the dose may be increased to 300 mg once daily if 24-hour urine protein excretion remains above 1 gram and no serious treatment-related adverse events have occurred. Following the treatment period, there will be a 4-week safety follow-up to monitor participants' health. Throughout the study, researchers will regularly measure and monitor urine protein excretion, urine protein-to-creatinine ratio, kidney filtration rate, presence of blood in the urine, and fatigue levels using a specialized assessment tool. These evaluations occur every 12 to 24 weeks during the 48-week treatment. The study also tracks the incidence and severity of adverse events to understand the treatment's safety. Participants must maintain stable background therapies and vaccinations as required.
CONDITIONS
Brief Title
A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297.
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m² at screening.
- Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study.
- Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed).
- Fertile females must have a negative serum pregnancy test and use highly effective contraception from consent until 30 days after last dose.
- Fertile males must use highly effective contraception from consent until 90 days after last dose.
- Voluntarily provided written informed consent and able to comply with study procedures.
You will not qualify if you...
- Known or suspected hereditary or acquired complement deficiency.
- Active primary or secondary immunodeficiency.
- History of bone marrow, hematopoietic stem cell, or solid organ transplantation.
- Malignancy within the past 5 years, except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of recurrent invasive infections caused by encapsulated bacteria or Mycobacterium tuberculosis.
- Severe concomitant diseases judged by the investigator to be incompatible with study participation.
- Suspected hypersensitivity to the investigational product or its class.
- Pregnant or lactating females.
- Other conditions that may interfere with the study or increase subject risk.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive HSK39297 tablets starting with 200 mg once daily, with a possible dose increase to 300 mg once daily after 8 to 12 weeks if certain criteria are met. Treatment lasts up to 48 weeks during which safety and efficacy are monitored.
Visits every 12 weeks for assessments; additional assessments every 24 weeks for kidney function
Trial Site Locations
Total: 2 locations
1
Peking University First Hospital
Beijing, China
Completed
2
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
L
li fangqiong Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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