Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN

NCT06670352 | Recruiting Phase 2

• 1 other identifier: HSK39297-202
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

HSK39297 50mg BID

EXPERIMENTAL

Drug: HSK39297 50mgBID

HSK39297 100mg BID

EXPERIMENTAL

Drug: HSK39297 100mgBID

HSK39297 200mg QD

EXPERIMENTAL

Drug: HSK39297 200mgQD

Interventions

Placebo DRUG

QD or BID, 24-weeks fixed dose.

Placebo

HSK39297 50mgBID DRUG

24-weeks fixed dose.

HSK39297 50mg BID

HSK39297 100mgBID DRUG

24-weeks fixed dose.

HSK39297 100mg BID

HSK39297 200mgQD DRUG

24-weeks fixed dose.

HSK39297 200mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 five years.
• Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
• Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.

You may not qualify if:

• 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), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 1, 2024
• Study Start: October 12, 2024
• Primary Completion: November 23, 2025
• Study Completion: March 15, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (2)