Clinical trial NCT06670352: Phase II 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 II Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients with Primary IgAN
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: IgA Nephropathy (IgAN)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment
timeFrame: From week 1 to week 12
Secondary outcomes:
measure: The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 24 weeks of treatment
timeFrame: From week 1 to week 24
measure: The ratio of 24h-UPCR compared to baseline at each clinical visit point during the treatment period
timeFrame: From week 1 to week 24
measure: The ratio of 24-hour urine protein (24h-UPE) compared to baseline at each clinical visit point during the treatment period
timeFrame: From week 1 to week 24
measure: The change in estimated glomerular filtration rate (eGFR, CKD-EPI 2021 formula) compared to baseline at each clinical visit point during the treatment period
timeFrame: From week 1 to week 24
measure: The change in blood creatinine compared to baseline at each clinical visit point during the treatment period
timeFrame: From week 1 to week 24
measure: The ratio of FMV UPCR, urinary albumin to creatinine ratio (UACR) compared to baseline at each clinical visit point during the treatment period
timeFrame: From week 1 to week 24
measure: 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
timeFrame: From week 1 to week 24
measure: Incidence , severity and relationship of adverse events during the study period
timeFrame: From week 1 to week 24
measure: Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) of HSK39297
timeFrame: From week 1 to week 24
measure: Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) of HSK39297
timeFrame: From week 1 to week 24
measure: Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) of HSK39297
timeFrame: From week 1 to week 24
measure: Plasma Pharmacokinetics (PK) of Maximum Concentrations (Cmax,ss) at Steady State of HSK39297
timeFrame: From week 1 to week 24
measure: Changes in alternative pathway (AP) complement activity compared to baseline at each clinical visit point during the treatment period
timeFrame: From week 1 to week 24
measure: Changes in plasma Bb levels compared to baseline at each clinical visit point during the treatment period
timeFrame: From week 1 to week 24
measure: Changes in plasma and urine sC5b-9 levels compared to baseline at each clinical visit point during the treatment period
timeFrame: From week 1 to week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
References: