New pill aims to tame kidney disease in Long-Term trial
NCT ID NCT07616700
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new tablet called HSK39297 for people with IgA nephropathy, a kidney disease that can lead to kidney failure. The trial includes 73 adults who have already taken the drug in a previous study. They will take the tablet once daily for an extended period, with a possible dose increase if needed. The main goal is to check long-term safety and how well the drug controls protein in the urine, a key sign of kidney damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HSK39297 tablets
- What this could lead to
- If successful, this could point toward a new oral treatment option to control IgA nephropathy and reduce kidney damage over the long term.
- What could go wrong
- This is an early Phase 2 study with only 73 participants and no placebo group, so results may not confirm effectiveness. Long-term safety is still unknown, and the drug may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 73 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297. 2. eGFR ≥30 mL/min/1.73 m² at screening (calculated by CKD-EPI 2021 equation). 3. Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study. 4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed). 5. Fertile females: negative serum pregnancy test; highly effective contraception from signing informed consent until 30 days after last dose. Fertile males: highly effective contraception from signing informed consent until 90 days after last dose. 6. Voluntarily provided written informed consent and able to comply with study procedures Exclusion Criteria: 1. Known or suspected hereditary or acquired complement deficiency. 2. Active primary or secondary immunodeficiency. 3. History of bone marrow / hematopoietic stem cell or solid organ transplantation. 4. Malignancy within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix). 5. History of recurrent invasive infections caused by encapsulated bacteria (e.g., N. meningitidis, S. pneumoniae) or Mycobacterium tuberculosis. 6. Severe concomitant diseases judged by the investigator to be incompatible with study participation. 7. Suspected hypersensitivity to the investigational product or its class. 8. Pregnant or lactating females. 9. Other conditions that may interfere with the study or increase subject risk.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
COMPLETEDBeijing, China
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Peking University First Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood test may help doctors Fine-Tune kidney disease therapy
- Can a daily pill protect kidneys in IgA nephropathy? MRI study puts atrasentan to the test
- Can AI learn to spot kidney disease in biopsy images?
- Can a single injection drug calm the immune attack on kidneys?
- Can a new pill slow kidney damage in IgA nephropathy?
- Can a gut metabolite shield the kidneys in IgA nephropathy?