The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.

Launched by RIVER 3 RENAL CORP. · Sep 13, 2024

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ClinConnect Summary

This clinical trial is studying a new drug called R3R01 to see if it can help reduce the amount of protein that people with type 2 diabetes and kidney disease lose in their urine. High levels of protein in urine can be a sign that the kidneys are not working properly. The trial will involve adults over 18 years old, specifically those with controlled diabetes and certain kidney function levels. Participants should be stable on their blood pressure and cholesterol medications.

If you decide to participate, you will take either R3R01 or a placebo (a dummy pill) for three months, along with regular check-ups that include blood and urine tests. The study will also monitor your kidney function and blood pressure using a special device. The trial is currently recruiting participants and aims to include both men and women, while ensuring that those who can become pregnant take precautions during the study. This research will help determine if R3R01 can be a beneficial treatment for people facing kidney issues due to diabetes.

Gender

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Eligibility criteria

• 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.
• • 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: \> 88 cm, Men: \> 102 cm or fasting triglyceride \>2.0 mmol/l.
• • 9. Systolic blood pressure (office) ≥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.