Tests R3R01 tablets against placebo for protein in urine in diabetic kidney disease

Trial details

Who runs it

River 3 Renal Corp.

Trial code

NCT06600412

Record updated

23 September 2026

Original description

The goal of this clinical trial is to to investigate whether the drug R3R01 has a beneficial effect on the amount of protein excreted in the urine in adult patients (above 18 years of age) with type 2 diabetes and resulting kidney disease.Read full original descriptionShow less

Effects of the ABCA1 Inducer R3R01 on Albuminuria Levels in Diabetic Kidney Disease

The goal of this clinical trial is to to investigate whether the drug R3R01 has a beneficial effect on the amount of protein excreted in the urine in adult patients (above 18 years of age) with type 2 diabetes and resulting kidney disease.

The main questions it aims to answer are:

1. Does 3 months of treatment with 200mg of the drug R3R01 morning and evening have a beneficial effect on the amount of protein excreted in the urine in patients with type 2 diabetes and kidney disease? 2. Does R3R01 have an effect on kidney function and daily blood pressure?

Researchers will compare the results of 40 people who take R3R01 to 20 people who receive an inactive substance (placebo).

Participants will receive R3R01 or the placebo as an oral tablet and undergo a selection of medical examinations - such as:

* blood samples * urine tests * kidney tests involving a radiolabelled marker which is injected into the bloodstream and monitored via blood samples * 24 hour blood pressure monitoring via a wearable device * urine pregnancy test (if applicable)

Inclusion: Adults (above 18 years of age) with controlled type 2 diabetes (hemoglobin A1c less than 10.5%); Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration; Titrated to the maximal dose or maximal tolerated dose of renin-angiotensin blocking treatment; Stable treatment with lipid lowering agents for at least 4 weeks; People on SGLT2-Inhibitors should be on a stable dose of the drug for at least 3 months; UACR >30 mg/g and < 5000 mg/g on two consecutive measurements; eGFR >30 ml/min/1.73 m2 (CKD-EPIcrea formula); Abdominal obesity Women: > 80 cm, Men: > 95 cm or fasting triglyceride >2.0 mmol/l; Systolic blood pressure ≥110 mmHg and ≤160 mmHg; 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; 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: Immunosuppressive therapy or immunosuppression the prior 6 months; Active or planned treatment with a medication that interacts with R3R01; Polycystic kidney disease, ANCA-associated vasculitis, or lupus nephritis; Ongoing cancer treatment; Nephrotic syndrome; Failure to understand patient information or to collaborate with the investigator; History of hypersensitivity to study drug and/or any of its excipients; 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; Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; Impaired liver function (clinically significant); Pregnancy or lactation; 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.

ClinicalTrials.gov NCT06600412