New pill aims to protect kidneys in diabetes patients
NCT ID NCT06600412
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Steno Diabetes Center Copenhagen
RECRUITINGCopenhagen, Copenhagen, 2730, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own kidney cells hold off dialysis?
- 12,000 diabetes records put kidney risk under the microscope
- A simple blood ratio may predict diabetic kidney disease
- Can a Patient's own kidney cells slow kidney disease?
- Can we predict kidney damage in young diabetics before it starts?
- A blood test that could spot kidney trouble in diabetes?