Status:
RECRUITING
The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.
Lead Sponsor:
River 3 Renal Corp.
Collaborating Sponsors:
Region Hovedstadens Apotek
Copenhagen University Hospital at Herlev
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06600412
Start Date
October 10 2024
End Date
October 1 2026
Last Update
January 6 2026
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Copenhagen, Copenhagen, Denmark, 2730