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

May 27, 2026 updated by: Haisco Pharmaceutical Group Co., Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
QD or BID, 24-weeks fixed dose.
Experimental: HSK39297 50mg BID
Drug: HSK39297 50mgBID
24-weeks fixed dose.
Experimental: HSK39297 100mg BID
Drug: HSK39297 100mgBID
24-weeks fixed dose.
Experimental: HSK39297 200mg QD
Drug: HSK39297 200mgQD
24-weeks fixed dose.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment
Time Frame: From week 1 to week 12
From week 1 to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 24 weeks of treatment
Time Frame: From week 1 to week 24
From week 1 to week 24
The ratio of 24h-UPCR compared to baseline at each clinical visit point during the treatment period
Time Frame: From week 1 to week 24
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
Time Frame: From week 1 to week 24
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
Time Frame: From week 1 to week 24
From week 1 to week 24
The change in blood creatinine compared to baseline at each clinical visit point during the treatment period
Time Frame: From week 1 to week 24
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
Time Frame: From week 1 to week 24
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
Time Frame: From week 1 to week 24
0-52, the higher the score, the better the QOL.
From week 1 to week 24
Incidence , severity and relationship of adverse events during the study period
Time Frame: From week 1 to week 24
From week 1 to week 24
Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) of HSK39297
Time Frame: From week 1 to week 24
From week 1 to week 24
Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) of HSK39297
Time Frame: From week 1 to week 24
From week 1 to week 24
Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) of HSK39297
Time Frame: From week 1 to week 24
From week 1 to week 24
Plasma Pharmacokinetics (PK) of Maximum Concentrations (Cmax,ss) at Steady State of HSK39297
Time Frame: From week 1 to week 24
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
Time Frame: From week 1 to week 24
From week 1 to week 24
Changes in plasma Bb levels compared to baseline at each clinical visit point during the treatment period
Time Frame: From week 1 to week 24
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
Time Frame: From week 1 to week 24
From week 1 to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haisco Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSK39297-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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