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Diabetic Kidney DiseasePhase 2Kidney ABCNCT06600412

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

A Phase 2 study testing R3R01 in people with Diabetic Kidney Disease, run by River 3 Renal Corp. at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
R3R01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteDenmark
Study dates
10 Oct 2024to 1 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • eGFR >30 ml/min/1.73 m2 (CKD-EPIcrea formula).
  • Abdominal obesity Women: > 80 cm, Men: > 95 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Minh-Nguyêt Duong contact

+31628443389

mnduong@narrowrivermgmt.com

Denmark1 site, 1 recruiting

  • Steno Diabetes Center Copenhagen

    Copenhagen, Copenhagen, 2730

    Peter Rossing, Professor, +30913383, Peter.Rossing@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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

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:

Read more
  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)
Read the detailed description

An increasing amount of evidence suggests that lipid dysmetabolism and accumulation in the kidneys play a central role in the pathogenesis of kidney disease. This lipotoxicity, in turn, may contribute to the development of albuminuria and chronic kidney disease.

One may surmise that interventions that reduce or prevent the progression of kidney lipid accumulation protect against the progression of kidney disease, including diabetic kidney disease (DKD). Therefore, it is possible inhibiting cholesterol absorption, might effectively protect against lipid accumulation and related disease in the kidneys.

R3R01 is an ATP-binding cassette transporter A1 (ABCA1) inducer, which increases the efflux of cholesterol from the intracellular space in the kidney.

Persons with type 2 diabetes with moderate and severe albuminuria have a poor renal and cardiovascular prognosis. As albuminuria is viewed both as a risk marker but also as a target for intervention, any treatment with antiproteinuric effects could be beneficial. The role of ABCA1 inducer treatment on kidney parameters in diabetic kidney disease is not known. By investigating the impact of ABCA1 inducer treatment on albuminuria, it will be determined whether this intervention may represent a future treatment option.

This study is a single center, double-blind, placebo controlled, parallel group randomized (2:1) study, in 60 people with type 2 diabetes with moderate or severe albuminuria and estimated glomerular filtration rate (eGFR) above 30 ml/min/1.73m2. 40 people will take R3R01 whilst 20 people receive the placebo.

The study's primary objective is to evaluate the effect of 12 weeks treatment with R3R01 on albuminuria in the study population. In addition to a 12 week treatment period, there will be a follow-up period of approximately 24 weeks (168 days). The expected total duration of study participation is up to 36 weeks for each patient.

Being tested
R3R01, Placebo
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R3R01Drug

    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.

  • PlaceboDrug

    Please refer to arm/group description for further information.

Study groups in NCT06600412
Study groupRoleWhat they receive
R3R01ExperimentalR3R01 oral tablet (200 mg twice daily) for 12 weeks
Receives: Drug: R3R01
PlaceboPlacebo comparatorPlacebo oral tablet twice daily for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 weeks (84 days)

Secondary outcomes (5)

  1. 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)).

    Measured: 12 weeks (84 days)

  2. 24 hours ambulatory blood pressure

    24 hours ambulatory blood pressure (change from baseline to end of treatment at 12 weeks (84 days)).

    Measured: 12 weeks (84 days)

  3. Plasma Pharmacokinetics

    R3R01 plasma concentrations will be measured to determine Maximum plasma concentration (Cmax)

    Measured: 24 weeks (168 days)

  4. Plasma Pharmacokinetics

    R3R01 plasma concentrations will be measured to determine minimum blood plasma concentration (Cmin)

    Measured: 24 weeks (168 days)

  5. Plasma Pharmacokinetics

    R3R01 plasma concentrations will be measured to determine the half-life (T1/2)

    Measured: 24 weeks (168 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start10 Oct 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06600412
Sponsor's protocol ID
R3R01-DKD-201
Acronym
Kidney ABC
Status last verified
Sep 2026
First submitted
4 Sep 2024
Last updated
23 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing R3R01 in people with Diabetic Kidney Disease, run by River 3 Renal Corp. at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Minh-Nguyêt Duong (+31628443389, mnduong@narrowrivermgmt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary albumin-to-creatinine ratio (UACR) (time frame: 12 weeks (84 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06600412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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