The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabe… (NCT06600412) | Clinical Trial Compass
RecruitingPhase 2
The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.
Denmark60 participantsStarted 2024-10-10
Plain-language summary
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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Abdominal obesity Women: \> 80 cm, Men: \> 95 cm or fasting triglyceride \>2.0 mmol/l.
Exclusion criteria
. Polycystic kidney disease, ANCA-associated vasculitis, or lupus nephritis.
. Ongoing cancer treatment.
. Immunosuppressive therapy or immunosuppression the prior 6 months.
. Nephrotic syndrome.
. Impaired liver function (clinically significant).
. Pregnancy or lactation.
. Failure to understand patient information or to collaborate with the investigator.
. 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.