💬In plain words
What the trial is, and whether it could suit you
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 i
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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