Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN
NCT ID: NCT06670352
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-10-12
2026-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
QD or BID, 24-weeks fixed dose.
HSK39297 50mg BID
HSK39297 50mgBID
24-weeks fixed dose.
HSK39297 100mg BID
HSK39297 100mgBID
24-weeks fixed dose.
HSK39297 200mg QD
HSK39297 200mgQD
24-weeks fixed dose.
Interventions
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Placebo
QD or BID, 24-weeks fixed dose.
HSK39297 50mgBID
24-weeks fixed dose.
HSK39297 100mgBID
24-weeks fixed dose.
HSK39297 200mgQD
24-weeks fixed dose.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Countries
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Facility Contacts
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Other Identifiers
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HSK39297-202
Identifier Type: -
Identifier Source: org_study_id
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