CompletedPhase 2

Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN

China87 participantsStarted 2024-10-12

Plain-language summary

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects must have signed and dated an IRB/IEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
. Female and male patients above 18 years of age.
. Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
. Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior five years.
. Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.

Exclusion criteria

. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
. All transplanted patients (any organ, including bone marrow).
. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment

Timeframe: From week 1 to week 12

Trial details

NCT IDNCT06670352

SponsorHaisco Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-20

View on ClinicalTrials.gov More IgA Nephropathy (IgAN) trials