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New pill aims to tame kidney disease in Long-Term trial

NCT ID NCT07616700

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 73 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking University First Hospital

    COMPLETED

    Beijing, China

  • Peking University First Hospital

    RECRUITING

    Beijing, China

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