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New pill aims to delay dialysis and save hearts in kidney patients

NCT ID NCT07625774

Disease control Sponsor: Shandong Suncadia Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This large Phase 3 study tests whether the drug HRS-7535 can help people with chronic kidney disease (CKD) avoid serious outcomes like kidney failure, dialysis, or heart-related death. About 3690 adults with CKD will receive either the drug or a placebo, added to their usual care. The goal is to see if HRS-7535 slows kidney decline and lowers cardiovascular risks over time.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,690 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

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

18 years and older

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. Male or female subjects, Age ≥ 18 years at the time of signing informed consent; 2. Clinically diagnosed with chronic kidney disease at screening; 3. CKD treatment plan consistent with current clinical guidelines or local standard of care; 4. eGFR ≥ 20 mL/min/1.73 m² and UACR meeting protocol-specified criteria at screening and prior to randomization; 5. Able and willing to provide a written informed consent; Exclusion Criteria: 1. Uncontrolled severe hypertension prior to randomization (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg); or systolic blood pressure \< 90 mmHg. 2. Body mass index (BMI) \< 20 kg/m² at screening and prior to randomization. 3. Prior history of renal transplantation, or planned renal transplantation during the trial; 4. History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). 5. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatable gallbladder disease (excluding cholecystectomy recipients); 6. Occurrence of acute kidney injury or receipt of dialysis treatment within 3 months prior to screening or randomization; 7. Presence of severe gastrointestinal diseases within 3 months prior to screening or randomization, or a history of major gastrointestinal surgery affecting gastric accommodation or gastric emptying; 8. Any condition deemed inappropriate for participation in this clinical trial by the investigator.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.