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โ† Trials
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Phase โ…ข Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN

RecruitingPhase 3Ages 18 Years - anyAllHaisco Pharmaceutical Group Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ten years. 5. 24h-UPCR โ‰ฅ0.75g/g or 24h-UPEโ‰ฅ1.0g/24h at screening. 6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) โ‰ฅ30 mL/min per 1.73 m2.For patients with eGFR\* 20 to \<30ml/min/1.73m2, a qualifying biopsy performed in two years. 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). 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 (โ‰ฅ 400mL) within 12 weeks prior to first dosing.
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What it tests

  • HSK39297
  • Placebo
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Where

9 sites
Huangshan City People's Hospital
Huangshan City, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, China
Peking University First Hospital
Beijing, China
Zhanjiang Central Hospital
Zhanjiang, China
Xiangya Hospital of Central South University
Changsha, China
The Second Hospital of Jilin University
Changchun, China
Linyi City People Hospital
Linyi, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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