NCT06670352CompletedPhase 2
Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
A Randomized, Double-blind, and Placebo-controlled Parallel Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 15 Oct 2024
- Start date
- 12 Oct 2024
- Primary completion date
- 20 Dec 2025
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- IgA nephropathy
- NCT number
- NCT06670352
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 87
- From 12 Oct 2024 to the primary completion date, 20 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
- Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
Other illness
- 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.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
Other
- All transplanted patients (any organ, including bone marrow).
- Pregnant or nursing (lactating) women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.