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

Launched by HAISCO PHARMACEUTICAL GROUP CO., LTD. · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HSK39297 tablets to see how effective and safe it is for people with IgA Nephropathy (IgAN), a condition that affects the kidneys. The trial is currently looking for participants aged 18 and older who have been diagnosed with IgAN through a kidney biopsy within the last five years. To join, individuals should have specific kidney function levels and a certain amount of protein in their urine. It’s important that participants are not currently using other investigational drugs and do not have a history of certain serious medical conditions.

If someone decides to participate, they will need to attend regular visits and undergo various tests to monitor their health and the medication's effects. This trial aims to help researchers understand how well the HSK39297 tablets work in treating IgAN and to ensure that they are safe for patients. Overall, this is an important step in finding better treatments for kidney diseases, and participants may contribute significantly to this research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Female and male patients above 18 years of age.
• • 3. 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
• • 4. Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior five years.
• • 5. Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
• • 6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.
• Exclusion Criteria:
• • 1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
• • 2. All transplanted patients (any organ, including bone marrow).
• • 3. 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.
• • 4. 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.
• • 5. Pregnant or nursing (lactating) women.
• • 6. Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.