Evaluating R3R01 for reducing protein in urine for diabetic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of the drug R3R01 on protein excretion in urine among adults with type 2 diabetes and diabetic kidney disease. Participants will receive either R3R01 or a placebo for three months, with assessments including blood samples, urine tests, and kidney function monitoring. The study aims to determine if R3R01 can reduce albuminuria and improve kidney function, potentially offering a new treatment option for this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Steno Diabetes Center Copenhagen
  Copenhagen, Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Peter Rossing, dr.med. — Steno Diabetes Center Copenhagen
• Study coordinator: Minh-Nguyêt Duong
• Email: mnduong@narrowrivermgmt.com
• Phone: +31628443389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.