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Biomarker-Guided cocktail aims to slow kidney failure

NCT ID NCT07239570

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether using specific biomarkers to choose and combine three kidney-protecting drugs (dapagliflozin, semaglutide, and finerenone) can slow kidney function decline better than standard care. About 125 adults with chronic kidney disease and albuminuria will be randomly assigned to either the biomarker-guided approach or usual treatment. The goal is to see if personalized drug sequencing preserves kidney function over two years.

What this could mean

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

Active substance
Dapagliflozin, Semaglutide, Finerenone
What this could lead to
If successful, this could show that matching drugs to individual biomarkers slows kidney function decline better than standard care, improving long-term outcomes for millions with chronic kidney disease.
What could go wrong
This is a phase 4 trial with 125 participants, so results may not apply to all patients. The benefit over standard care may be small, and side effects from combining these drugs are possible.

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

About 125 people

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

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 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: 1. Age ≥ 18 and ≤ 75 years 2. UACR 100-5000 mg/g (11.3-565 mg/mmol) in two consecutive first-morning void urine samples at screening. (UACR 80-100 mg/g is accepted if historical measurements are above 100 mg/g and if it cannot be explained by any new treatment.) 3. Stable treatment with a maximum tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least four weeks prior to randomization. (Unless such treatment is contraindicated or not tolerated.) 4. Ability to communicate with the study staff and understand and sign the informed consent. Exclusion Criteria: 1. eGFR \< 25 mL/min/1.73m2 at screening. 2. Treatment with two or all three of the study drugs 3. History of pancreatitis at screening 4. Body mass index \< 18.5 kg/m2 at screening 5. Type 1 diabetes 6. Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment 7. NYHA class IV Congestive Heart Failure at screening 8. Potassium \> 5.0 mmol/L at screening 9. Addison's Disease 10. Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin) 11. Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride) 12. Elevated Alanine Aminotransferase (ALT) \> 3 x upper normal limit at screening, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt). 13. Autosomal dominant or autosomal recessive polycystic kidney disease 14. Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening 15. Kidney transplant or dialysis 16. Known or suspected hypersensitivity to the study medications or related products 17. Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening. 18. Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements. 19. A female who is pregnant, breastfeeding, or intends to become pregnant, or a woman of childbearing potential (WOCBP) who is not using highly effective contraceptive methods. 20. Known or suspected abuse of narcotics. 21. Participant in another intervention study. 22. Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent).

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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

    4 sites in 4 countries. 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

  • Hospital Clinico de Valencia

    NOT_YET_RECRUITING

    Valencia, Spain

  • Lund University

    NOT_YET_RECRUITING

    Malmö, Sweden

  • Steno Diabetes Center Copenhagen

    RECRUITING

    Herlev, Denmark

  • University Medical Center Hamburg-Eppendorf

    NOT_YET_RECRUITING

    Hamburg, Germany

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