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)
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.
Polycystic kidney disease, ANCA-associated vasculitis, or lupus nephritis.
Ongoing cancer treatment.
Immunosuppressive therapy or immunosuppression the prior 6 months.
Nephrotic syndrome.
Parallel
R3R01
DrugR3R01 is an ATP-binding cassette transporter A1 (ABCA1) inducer, which increases the efflux of cholesterol from the intracellular space in the kidney. Please refer to arm/group description for further information.
Placebo
DrugPlease refer to arm/group description for further information.
Urinary albumin-to-creatinine ratio (UACR)
Urinary albumin-to-creatinine ratio (UACR) (Change from baseline to end of treatment at 12 weeks (84 days).
Measured or Estimated Glomerular Filtration Rate
Measured glomerular filtration rate (GFR) with plasma clearance of 99Tc-DTPA or eGFR measured with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on creatinine and/or cystatin C (change from baseline to end of treatment at 12 weeks (84 days)).
24 hours ambulatory blood pressure
24 hours ambulatory blood pressure (change from baseline to end of treatment at 12 weeks (84 days)).
Plasma Pharmacokinetics
R3R01 plasma concentrations will be measured to determine Maximum plasma concentration (Cmax)
Plasma Pharmacokinetics
R3R01 plasma concentrations will be measured to determine minimum blood plasma concentration (Cmin)
Click on the lead sponsor to view all of their trials.
River 3 Renal Corp.
Lead sponsor
Region Hovedstadens Apotek
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Q2 Solutions
Collaborator
LUMIS International GmbH
Collaborator
