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

Official title

A Randomized, Double-blind, and Placebo-controlled Parallel Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN

Overview

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

Interventions

• Drug HSK39297
  HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose.
• Drug Placebo
  Placebo, once a day; treatment period; 48-weeks fixed dose.

Primary outcome measures

• Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks [Time frame: From week 1 to week 36]
• Annualized total estimated Glomerular Filtration Rate slope over 48 weeks [Time frame: From week 1 to week 48]

Secondary outcome measures (3)

• Annualized total estimated Glomerular Filtration Rate slope over 36 weeks [Time frame: From week 1 to week 36]
• Annualized total estimated Glomerular Filtration Rate slope over 104 weeks [Time frame: From week 1 to week 104]
• Incidence , severity and relationship of adverse events during the study period [Time frame: From week 1 to week 108]

Eligibility criteria

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 ten years.
• 24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
• Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 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

• 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).
• 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.
• Pregnant or nursing (lactating) women.
• Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 9 centers

• Huangshan City People's Hospital — Huangshan City
• The Second Affiliated Hospital of Wannan Medical College — Wuhu
• Peking University First Hospital — Beijing
• Zhanjiang Central Hospital — Zhanjiang
• Xiangya Hospital of Central South University — Changsha
• The Second Hospital of Jilin University — Changchun
• Linyi City People Hospital — Linyi
• Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai
• … and 1 more center

Identifiers

NCT: NCT07390123 · HSK39297-303

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗