Actively Recruiting
The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.
Led by River 3 Renal Corp. · Updated on 2026-04-03
60
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
R
River 3 Renal Corp.
Lead Sponsor
R
Region Hovedstadens Apotek
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults above 18 years of age with controlled type 2 diabetes (hemoglobin A1c less than 10.5%)
- Stable antihypertensive treatment for at least 4 weeks before and during the study
- Titrated to maximal or maximal tolerated dose of renin-angiotensin blocking treatment
- Stable lipid-lowering treatment for at least 4 weeks
- Stable dose of SGLT2-Inhibitors for at least 3 months if used
- Urinary albumin-to-creatinine ratio between 30 mg/g and 5000 mg/g on two consecutive tests
- Estimated glomerular filtration rate (eGFR) above 30 ml/min/1.73 m2
- Abdominal obesity (Women: waist circumference > 80 cm, Men: > 95 cm) or fasting triglyceride > 2.0 mmol/l
- Systolic blood pressure between 110 and 160 mmHg
- Female patients and female partners of male patients of child-bearing potential must agree to avoid pregnancy during the study and for 90 days after last dose
- Males with female partners of child-bearing potential must use contraception during the study and for 90 days after last dose and report pregnancies immediately
You will not qualify if you...
- Polycystic kidney disease, ANCA-associated vasculitis, or lupus nephritis
- Ongoing cancer treatment
- Immunosuppressive therapy or immunosuppression within the past 6 months
- Nephrotic syndrome
- Clinically significant impaired liver function
- Pregnancy or breastfeeding
- Inability to understand study information or cooperate with investigators
- Females of childbearing potential not using effective contraception
- Known allergy to study drug or its ingredients
- Hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
- Use or planned use of medications that interact with R3R01
- Any medical condition that poses risk or may affect study results, including substance abuse or psychiatric disorders
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Trial Site Locations
Total: 1 location
1
Steno Diabetes Center Copenhagen
Copenhagen, Copenhagen, Denmark, 2730
Actively Recruiting
Research Team
M
Minh-Nguyêt Duong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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