IgA Nephropathy (IgAN)Phase 2NCT06670352
Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
A Phase 2 study testing HSK39297 50mgBID, HSK39297 100mgBID and HSK39297 200mgQD in people with IgA Nephropathy (IgAN), run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- HSK39297 50mgBID, HSK39297 100mgBID and HSK39297 200mgQD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 2 sitesChina
- Study dates
- 12 Oct 2024to 15 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
About this study
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
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- Placebo, HSK39297 50mgBID, HSK39297 100mgBID, HSK39297 200mgQD
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
QD or BID, 24-weeks fixed dose.
HSK39297 50mgBIDDrug
24-weeks fixed dose.
HSK39297 100mgBIDDrug
24-weeks fixed dose.
HSK39297 200mgQDDrug
24-weeks fixed dose.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| HSK39297 50mg BID | Experimental | Not described Receives: Drug: HSK39297 50mgBID |
| HSK39297 100mg BID | Experimental | Not described Receives: Drug: HSK39297 100mgBID |
| HSK39297 200mg QD | Experimental | Not described Receives: Drug: HSK39297 200mgQD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment
Measured: 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
Measured: From week 1 to week 24
The ratio of 24h-UPCR compared to baseline at each clinical visit point during the treatment period
Measured: 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
Measured: 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
Measured: From week 1 to week 24
The change in blood creatinine compared to baseline at each clinical visit point during the treatment period
Measured: 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
Measured: 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
0-52, the higher the score, the better the QOL.
Measured: From week 1 to week 24
Incidence , severity and relationship of adverse events during the study period
Measured: From week 1 to week 24
Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) of HSK39297
Measured: From week 1 to week 24
Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) of HSK39297
Measured: From week 1 to week 24
Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) of HSK39297
Measured: From week 1 to week 24
Plasma Pharmacokinetics (PK) of Maximum Concentrations (Cmax,ss) at Steady State of HSK39297
Measured: 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
Measured: From week 1 to week 24
Changes in plasma Bb levels compared to baseline at each clinical visit point during the treatment period
Measured: 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
Measured: From week 1 to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start12 Oct 2024
- Primary completion20 Dec 2025
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670352
- Sponsor's protocol ID
- HSK39297-202
- Status last verified
- May 2026
- First submitted
- 15 Oct 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06670352
- Acronym / sponsor ID
- HSK39297-202
- Conditions
- IgA Nephropathy (IgAN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboQD or BID, 24-weeks fixed dose. | Drug | Placebo |
| HSK39297 50mgBID24-weeks fixed dose. | Drug | HSK39297 50mg BID |
| HSK39297 100mgBID24-weeks fixed dose. | Drug | HSK39297 100mg BID |
| HSK39297 200mgQD24-weeks fixed dose. | Drug | HSK39297 200mg QD |
Primary outcome
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
15 secondary outcomes
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
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
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
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
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
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
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
Incidence , severity and relationship of adverse events during the study period
Time frame: 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
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
Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) of HSK39297
Time frame: 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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK39297 50mgBID, HSK39297 100mgBID and HSK39297 200mgQD in people with IgA Nephropathy (IgAN), run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.