Phase
Condition
Diabetic Kidney Disease
Treatment
Placebo
R3R01
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults (above 18 years of age) with controlled type 2 diabetes (hemoglobin A1c lessthan 10.5%).
Stable antihypertensive treatment 4 weeks before start of study drug and throughoutstudy duration.
Titrated to the maximal dose or maximal tolerated dose of renin-angiotensin blockingtreatment.
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 3months.
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 ofchild-bearing potential must be willing to not become pregnant for the completeduration of the study and 90 days after the last dose of study medication.
Males (including sterilized subjects) whose female partners have child-bearingpotential, must agree to use male contraception (condoms) during the period from thetime of signing the informed consent form through 90 days after the last dose ofstudy drug. They must agree to immediately inform the investigator if their partnerbecomes pregnant during the study.
Exclusion
Exclusion Criteria:
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 orpost-menopausal for at least 1 year) are excluded from participation in the studyunless 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-galactosemalabsorption.
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 studyresults in the investigators opinion, or that the investigator deems unsuitable forthe study including drug or alcohol abuse or psychiatric, behavioral, or cognitivedisorders sufficient to interfere with the patient's ability to understand andcomply with the protocol instructions or follow-up procedures.
Study Design
Study Description
Connect with a study center
Steno Diabetes Center Copenhagen
Copenhagen 2618425, Copenhagen 2730
DenmarkActive - Recruiting
Steno Diabetes Center Copenhagen
Copenhagen, 2730
DenmarkSite Not Available

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