RecruitingPhase 2NCT06600412

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

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


Sponsor

River 3 Renal Corp.

Enrollment

60 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is investigating whether a drug called R3R01 — which works by helping the kidneys remove excess cholesterol — can reduce the amount of protein leaking into the urine in adults with type 2 diabetes and kidney disease, a sign of kidney damage. Researchers believe that lipid buildup in kidney cells contributes to diabetic kidney disease, and that R3R01 may protect the kidneys by reversing this. Adults over 18 with controlled type 2 diabetes, kidney protein leakage (UACR between 30 and 5000 mg/g), and adequate kidney function (eGFR above 30) who are on stable treatments for blood pressure and cholesterol may be eligible. Participation involves taking R3R01 or placebo tablets twice daily for 12 weeks with follow-up assessments including blood tests, urine tests, kidney function measurements, and 24-hour blood pressure monitoring, with follow-up continuing for up to 36 weeks total. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR3R01

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.

DRUGPlacebo

Please refer to arm/group description for further information.


Locations(1)

Steno Diabetes Center Copenhagen

Copenhagen, Copenhagen, Denmark

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NCT06600412


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