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

NCT06600412 | Recruiting Phase 2

• 1 other identifier: R3R01-DKD-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Outcome Measures

Primary Outcomes (1)

• Urinary albumin-to-creatinine ratio (UACR)

  Urinary albumin-to-creatinine ratio (UACR) (Change from baseline to end of treatment at 12 weeks (84 days).

  12 weeks (84 days)

Secondary Outcomes (5)

• Measured or Estimated Glomerular Filtration Rate

  12 weeks (84 days)

• 24 hours ambulatory blood pressure

  12 weeks (84 days)

• Plasma Pharmacokinetics

  24 weeks (168 days)

• Plasma Pharmacokinetics

  24 weeks (168 days)

• Plasma Pharmacokinetics

  24 weeks (168 days)

Study Arms (2)

R3R01

EXPERIMENTAL

R3R01 oral tablet (200 mg twice daily) for 12 weeks

Drug: R3R01

Placebo

PLACEBO COMPARATOR

Placebo oral tablet twice daily for 12 weeks

Drug: Placebo

Interventions

R3R01 DRUG

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.

R3R01

Placebo DRUG

Please refer to arm/group description for further information.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• People on SGLT2-Inhibitors should be on a stable dose of the drug for at least 3 months.
• UACR \>30 mg/g and \< 5000 mg/g on two consecutive measurements.
• eGFR \>30 ml/min/1.73 m2 (CKD-EPIcrea formula).
• Abdominal obesity Women: \> 88 cm, Men: \> 102 cm or fasting triglyceride \>2.0 mmol/l.
• Systolic blood pressure ≥110 mmHg and ≤160 mmHg.
• Both female patients, as well as female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study and 90 days after the last dose of study medication.
• Males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form through 90 days after the last dose of study drug. They must agree to immediately inform the investigator if their partner becomes pregnant during the study.

You may not qualify if:

• Polycystic kidney disease, ANCA-associated vasculitis, or lupus nephritis.
• Ongoing cancer treatment.
• Immunosuppressive therapy or immunosuppression the prior 6 months.
• Nephrotic syndrome.
• Impaired liver function (clinically significant).
• Pregnancy or lactation.
• Failure to understand patient information or to collaborate with the investigator.
• Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study unless they agree to use highly effective contraception.
• History of hypersensitivity to study drug and/or any of its excipients.
• Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
• Active or planned treatment with a medication that interacts with R3R01.
• Any other medical condition(s) that might put the patient at risk or influence study results in the investigators opinion, or that the investigator deems unsuitable for the study including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.

Sponsors & Collaborators

• River 3 Renal Corp.: lead
• Region Hovedstadens Apotek: collaborator
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Copenhagen, Copenhagen, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Peter Rossing, dr.med.

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minh-Nguyêt Duong

CONTACT

+31628443389; mnduong@narrowrivermgmt.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)