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New treatment option for Diabetic Kidney Disease
Official title The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.
ClinicalTrials.gov ID: NCT06600412
What this study is testing
What is R3R01?
R3R01 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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).
- 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...
- Males (including sterilized people) 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...
- 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.
- History of hypersensitivity to study drug and/or any of its excipients.
- Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Active or planned treatment with a medication that interacts with R3R01.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.