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

NCT06600412 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-03

No results posted yet for this study

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)

Conditions

  • Diabetic Kidney Disease

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.

Sponsors & Collaborators

  • Region Hovedstadens Apotek

    collaborator OTHER_GOV

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • River 3 Renal Corp.

    lead INDUSTRY

Principal Investigators

  • Peter Rossing, dr.med. · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06600412 on ClinicalTrials.gov