A Phase 2 interventional study of R3R01 and Placebo in Diabetic Kidney Disease, sponsored by River 3 Renal Corp.. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by River 3 Renal Corp. · Phase 2, Interventional, and Treatment
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Among 41 studies in Diabetic Nephropathies with a site in Denmark — 5 open to participants now, 5 under way, none of them phase 3. Diabetic Nephropathies · Denmark.
Among the 41 studies in Diabetic Nephropathies with a site in Denmark, this one is the 18th largest by planned enrollment of the 35 interventional ones that give a count, is the only one that started in 2024, is one of 14 in phase 2, and was the 40th registered.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
Browse Diabetic Nephropathies studies →5 of the 41 studies in Diabetic Nephropathies with a site in Denmark are open now. Recruiting first, the newest first:
University of Aarhus · Sites in Denmark
Ages 40+
Herlev Hospital · Sites in Denmark
Ages 18–120
University Medical Center Groningen · Sites in Denmark, Finland
Ages 18–64
Steno Diabetes Center Copenhagen · Sites in Denmark, United Kingdom
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 50 Diabetic Nephropathies studies recruiting now, 23 (46%) set no upper age limit and 16 (32%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 15 · Phase 3 5 · Phase 4 10
First in 1993; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Median enrollment 60 across the 35 interventional studies, 144 across the 6 observational. Of the 31 that completed or were terminated, 8 (26%) have results posted.
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14 of 41 have an industry lead sponsor. The 10 most frequent:
River 3 Renal Corp. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
River 3 Renal Corp. has 1 study filed under Diabetic Nephropathies — fewer than ten, so there is no comparison to draw.
2 of the studies in Diabetic Nephropathies with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06600412River 3 Renal Corp.The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease. | 2027-04-01 |
| NCT06147232Steno Diabetes Center CopenhagenPrevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia | 2027-05 |
Add all 2 to your calendar (.ics) → With an account.
Among the 41 studies in Diabetic Nephropathies with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
R3R01 oral tablet (200 mg twice daily) for 12 weeks
Drug: R3R01
Placebo oral tablet twice daily for 12 weeks
Drug: Placebo
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.
Please refer to arm/group description for further information.
Urinary albumin-to-creatinine ratio (UACR)
Urinary albumin-to-creatinine ratio (UACR) (Change from baseline to end of treatment at 12 weeks (84 days).
Time frame: 12 weeks (84 days)
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)).
Time frame: 12 weeks (84 days)
24 hours ambulatory blood pressure
24 hours ambulatory blood pressure (change from baseline to end of treatment at 12 weeks (84 days)).
Time frame: 12 weeks (84 days)
Plasma Pharmacokinetics
R3R01 plasma concentrations will be measured to determine Maximum plasma concentration (Cmax)
Time frame: 24 weeks (168 days)
Plasma Pharmacokinetics
R3R01 plasma concentrations will be measured to determine minimum blood plasma concentration (Cmin)
Time frame: 24 weeks (168 days)
Plasma Pharmacokinetics
R3R01 plasma concentrations will be measured to determine the half-life (T1/2)
Time frame: 24 weeks (168 days)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Apr 2027, 29 months after the start.
Of 32 industry-sponsored phase 2 interventional studies under Diabetic Nephropathies, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 28. This study's planned 29 months is above that.
Counting every sponsor, half of 52 studies reached it within 21 months; a quarter within 13 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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River 3 Renal Corp.