IgA Nephropathy (IgAN)
Conditions
Brief summary
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Interventions
DRUGPlacebo
QD or BID, 24-weeks fixed dose.
DRUGHSK39297 50mgBID
24-weeks fixed dose.
DRUGHSK39297 100mgBID
24-weeks fixed dose.
DRUGHSK39297 200mgQD
24-weeks fixed dose.
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment | From week 1 to week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 24 weeks of treatment | From week 1 to week 24 | — |
| The ratio of 24h-UPCR compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | — |
| The ratio of 24-hour urine protein (24h-UPE) compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | — |
| The change in estimated glomerular filtration rate (eGFR, CKD-EPI 2021 formula) compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | — |
| The change in blood creatinine compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | — |
| The ratio of FMV UPCR, urinary albumin to creatinine ratio (UACR) compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | — |
| The change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale score compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | 0-52, the higher the score, the better the QOL. |
| Incidence , severity and relationship of adverse events during the study period | From week 1 to week 24 | — |
| Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) of HSK39297 | From week 1 to week 24 | — |
| Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) of HSK39297 | From week 1 to week 24 | — |
| Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) of HSK39297 | From week 1 to week 24 | — |
| Plasma Pharmacokinetics (PK) of Maximum Concentrations (Cmax,ss) at Steady State of HSK39297 | From week 1 to week 24 | — |
| Changes in alternative pathway (AP) complement activity compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | — |
| Changes in plasma Bb levels compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | — |
| Changes in plasma and urine sC5b-9 levels compared to baseline at each clinical visit point during the treatment period | From week 1 to week 24 | — |
Countries
China
Outcome results
None listed