BridgeMD
Kidney ABC
EU CTIS ID: 2024-511484-29-00
What this study is testing
To evaluate the efficacy of R3R01 in reducing albuminuria at 12 weeks (Day 84) when compared to placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female adults (above 18 years) with type 2 diabetes (controlled with hemoglobin A1c <10.5%).
- Both female patients, as well as female partners of male patients who are of childbearing potential must be willing to not become pregnant for the complete duration of the study (>180 days) (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 (ICF) 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
- 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.
You likely can't join if
- Polycystic kidney disease, ANCA-associated vasculitis or lupus nephritis
- 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.
- Ongoing cancer treatment
- Immunosuppressive therapy or immunosuppression in the prior 6 months
See the full eligibility criteria
Who can join
- Male or female adults (above 18 years) with type 2 diabetes (controlled with hemoglobin A1c <10.5%).
- Both female patients, as well as female partners of male patients who are of childbearing potential must be willing to not become pregnant for the complete duration of the study (>180 days) (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 (ICF) 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
- 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 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-EPI formula)
- Abdominal obesity (Waist circumference) Women: > 80 cm, Men: > 95 cm or fasting triglyceride >2.0 mmol/l based on historic laboratory values within 2 years before screening.
- Systolic blood pressure ≥110 mmHg and ≤160 mmHg.
What rules you out
- Polycystic kidney disease, ANCA-associated vasculitis or lupus nephritis
- 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.
- Ongoing cancer treatment
- Immunosuppressive therapy or immunosuppression in 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.