Phase II Study of Efficacy and Safety of HSK39297 Tablet... | NCT06670352

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

NCT06670352

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Status

Completed

Last Update Posted

May 28, 2026Actual

Enrollment

87Actual

Phase

Phase 2

Conditions

IgA Nephropathy (IgAN)

Interventions

Placebo
HSK39297 50mgBID
HSK39297 100mgBID
HSK39297 200mgQD

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2024Actual

Primary Completion Date

Dec 20, 2025Actual

Completion Date

May 15, 2026Actual

First Submitted Date

Oct 15, 2024

First Submission Date that Met QC Criteria

Oct 30, 2024

First Posted Date

Nov 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2026

Last Update Posted Date

May 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	QD or BID, 24-weeks fixed dose.	Placebo
HSK39297 50mgBID

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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 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.

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), 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing	Beijing Municipality	100034	China
Nanjing Drum Tower Hospital

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases