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RECRUITING
NCT06600412
PHASE2

The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.

Sponsor: River 3 Renal Corp.

View on ClinicalTrials.gov

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)

Official title: Effects of the ABCA1 Inducer R3R01 on Albuminuria Levels in Diabetic Kidney Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-10

Completion Date

2026-10

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

R3R01

R3R01 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.

DRUG

Placebo

Please refer to arm/group description for further information.

Locations (1)

Steno Diabetes Center Copenhagen

Copenhagen, Copenhagen, Denmark