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New pill aims to protect kidneys in diabetes patients

NCT ID NCT06600412

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests whether a new drug called R3R01 can reduce the amount of protein leaking into the urine in adults with type 2 diabetes and kidney disease. About 60 participants will take either R3R01 or a placebo for 3 months. Researchers will measure urine protein, kidney function, and blood pressure to see if the drug helps protect the kidneys.

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 60 people

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

Started

Oct 2024

Expected to finish

Apr 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 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. Adults (above 18 years of age) with controlled type 2 diabetes (hemoglobin A1c less than 10.5%). 2. Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration. 3. Titrated to the maximal dose or maximal tolerated dose of renin-angiotensin blocking treatment. 4. Stable treatment with lipid lowering agents for at least 4 weeks. 5. People on SGLT2-Inhibitors should be on a stable dose of the drug for at least 3 months. 6. UACR \>30 mg/g and \< 5000 mg/g on two consecutive measurements. 7. eGFR \>30 ml/min/1.73 m2 (CKD-EPIcrea formula). 8. Abdominal obesity Women: \> 80 cm, Men: \> 95 cm or fasting triglyceride \>2.0 mmol/l. 9. Systolic blood pressure ≥110 mmHg and ≤160 mmHg. 10. Both female patients, as well as female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study and 90 days after the last dose of study medication. 11. Males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form through 90 days after the last dose of study drug. They must agree to immediately inform the investigator if their partner becomes pregnant during the study. Exclusion Criteria: 1. Polycystic kidney disease, ANCA-associated vasculitis, or lupus nephritis. 2. Ongoing cancer treatment. 3. Immunosuppressive therapy or immunosuppression the prior 6 months. 4. Nephrotic syndrome. 5. Impaired liver function (clinically significant). 6. Pregnancy or lactation. 7. Failure to understand patient information or to collaborate with the investigator. 8. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study unless they agree to use highly effective contraception. 9. History of hypersensitivity to study drug and/or any of its excipients. 10. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. 11. Active or planned treatment with a medication that interacts with R3R01. 12. Any other medical condition(s) that might put the patient at risk or influence study results in the investigators opinion, or that the investigator deems unsuitable for the study including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.

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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

  • Steno Diabetes Center Copenhagen

    RECRUITING

    Copenhagen, Copenhagen, 2730, Denmark

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