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New hope for kidney patients: dapagliflozin trial targets slowing disease

NCT ID NCT06610526

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is testing the drug dapagliflozin in 731 Chinese adults with chronic kidney disease. The goal is to see if the drug can slow kidney decline and is safe. Participants take the drug by mouth, and researchers track kidney function and side effects over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dapagliflozin (a drug taken by mouth that helps protect the kidneys)
What this could lead to
If it works, this could provide a new treatment option to slow kidney disease progression in Chinese patients.
What could go wrong
This is a single-arm, open-label study without a placebo group, so results may be less reliable. It is also limited to Chinese adults, so findings may not apply to other populations.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

731 people

The number who actually took part.

Started

Aug 2024

Expected to finish

May 2027

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 to 130 years

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: * Provision of signed informed consent prior to any study specific procedures * Chinese Female or male aged ≥ 18 years at the time of consent * eGFR ≥ 25 and ≤ 75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1 * Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥ 200 and ≤ 5000 mg/g at visit 1 * Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated Exclusion Criteria: * Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibodies-associated vasculitis * Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment * History of organ transplantation * Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor * T1DM * New York Heart Association class IV Congestive Heart Failure at the time of enrolment * MI, unstable angina, stroke or TIA within 12 weeks prior to enrolment * Coronary revascularization (PCI or CABG) or valvular repair/replacement within 12 weeks prior to enrolment * Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma) * Hepatic impairment (AST or ALT \> 3 × ULN; or total bilirubin \> 2 × ULN at time of enrolment). An solated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion * Known blood-borne diseases * Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, from the time of signing the informed consent throughout the study and 4 weeks thereafter, OR women who have a positive pregnancy test at enrolment OR women who are breast-feeding * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or site personnel) * Previous enrolled in the present study * Participation in another clinical study with a study intervention during the last month prior to enrolment * Inability of the patient, in the opinion of the investigator, to understand and/or comply with study intervention, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study

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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.

Contacts and locations

Locations

  • Research Site

    Beijing, 100034, China

  • Research Site

    Beijing, 100044, China

  • Research Site

    Beijing, 100068, China

  • Research Site

    Beijing, 100191, China

  • Research Site

    Beijing, 102206, China

  • Research Site

    Changchun, 130021, China

  • Research Site

    Dongguan, 523059, China

  • Research Site

    Foshan, 528308, China

  • Research Site

    Fuyang, 236012, China

  • Research Site

    Fuzhou, 350001, China

  • Research Site

    Ganzhou, 341099, China

  • Research Site

    Harbin, 150000, China

  • Research Site

    Hefei, 230601, China

  • Research Site

    Hengyang, 421001, China

  • Research Site

    Huaian, 223399, China

  • Research Site

    Huizhou, 516001, China

  • Research Site

    Jilin City, 132011, China

  • Research Site

    Jinan, 250014, China

  • Research Site

    Jining, 272029, China

  • Research Site

    Lanzhou, 730000, China

  • Research Site

    Linyi, 276199, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Nanning, 530021, China

  • Research Site

    Ningbo, 315010, China

  • Research Site

    Shanghai, 200090, China

  • Research Site

    Shenzhen, 518036, China

  • Research Site

    Suzhou, 215004, China

  • Research Site

    Taian, 271099, China

  • Research Site

    Tianjin, 300121, China

  • Research Site

    Wuhu, 241000, China

  • Research Site

    Wuxi, 214023, China

  • Research Site

    Xi'an, 710000, China

  • Research Site

    Xiamen, 361004, China

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