The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.
Recruiting
Phase 2Interventional Study
Diabetic Kidney Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
River 3 Renal Corp. · Industry
Who this trial is looking for
This trial is looking for adults with type 2 diabetes and kidney disease. Participants will take a medication called R3R01 and undergo various tests to see how it affects protein in the urine and kidney function.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult over 18 years old.
I have type 2 diabetes.
I have a protein level in my urine between 30 and 5000 mg/g.
I have stable blood pressure between 110 and 160 mmHg.
I am currently on stable antihypertensive treatment.
I have an eGFR greater than 30 ml/min/1.73 m².
I agree to not become pregnant during the study.
I am on a stable dose of SGLT2-Inhibitors for at least 3 months.
You may not be able to join if
I have polycystic kidney disease.
I have ongoing cancer treatment.
I have had immunosuppressive therapy in the last 6 months.
I am currently pregnant or breastfeeding.
I have impaired liver function.
I cannot understand the patient information provided.
I have a history of hypersensitivity to the study drug.
I have active or planned treatment that interacts with R3R01.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 amoun…
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)
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adults (above 18 years of age) with controlled type 2 diabetes (hemoglobin A1c less than 10.5%).
2. Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration.
3. Titrated to the maximal dose or maximal tolerated dose of renin-angiotens…
Inclusion Criteria:
1. Adults (above 18 years of age) with controlled type 2 diabetes (hemoglobin A1c less than 10.5%).
2. Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration.
3. Titrated to the maximal dose or maximal tolerated dose of renin-angiotensin blocking treatment.
4. Stable treatment with lipid lowering agents for at least 4 weeks.
5. People on SGLT2-Inhibitors should be on a stable dose of the drug for at least 3 months.
6. UACR \>30 mg/g and \< 5000 mg/g on two consecutive measurements.
7. eGFR \>30 ml/min/1.73 m2 (CKD-EPIcrea formula).
8. Abdominal obesity Women: \> 80 cm, Men: \> 95 cm or fasting triglyceride \>2.0 mmol/l.
9. Systolic blood pressure ≥110 mmHg and ≤160 mmHg.
10. 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.
11. 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.
Exclusion Criteria:
1. Polycystic kidney disease, ANCA-associated vasculitis, or lupus nephritis.
2. Ongoing cancer treatment.
3. Immunosuppressive therapy or immunosuppression the prior 6 months.
4. Nephrotic syndrome.
5. Impaired liver function (clinically significant).
6. Pregnancy or lactation.
7. Failure to understand patient information or to collaborate with the investigator.
8. 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.
9. History of hypersensitivity to study drug and/or any of its excipients.
10. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
11. Active or planned treatment with a medication that interacts with R3R01.
12. 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.
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