Study on the Effects of R3R01 on Reducing Protein in Urine for Patients with Diabetic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for diabetic kidney disease, a condition that affects the kidneys of people with diabetes. The treatment being tested is a medication known by its code name R3R01, which is taken in the form of a tablet. The purpose of the study is to evaluate how effective R3R01 is in reducing the levels of a protein called albumin in the urine, which is a common issue in diabetic kidney disease.

Participants in the study will receive either the R3R01 tablet or a placebo, which is a substance with no active medication. The study will last for 12 weeks, during which time participants will take the medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study will also involve the use of a special solution called Technescan DTPA, which is injected to help measure kidney function.

The main goal is to see if R3R01 can lower the amount of albumin in the urine compared to the placebo. Additionally, the study will look at other factors such as kidney function and blood pressure. This research aims to provide new insights into managing diabetic kidney disease and improving treatment options for patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, type 2 diabetes status, and stable treatment with certain medications.

Participants must agree to use contraception if applicable and maintain stable health conditions as outlined in the study requirements.

2 randomization

Participants are randomly assigned to receive either the R3R01 medication or a placebo.

This process ensures that the study results are unbiased and scientifically valid.

3 medication administration

Participants receive the assigned treatment, which could be R3R01 or a placebo, for a duration of 12 weeks.

The R3R01 is administered orally in tablet form, while the placebo is also provided in a similar manner.

4 monitoring and assessments

Throughout the 12-week period, participants undergo regular monitoring to assess the effects of the treatment.

Key assessments include measuring the urinary albumin-to-creatinine ratio (UACR) and other health parameters such as blood pressure and kidney function.

5 end of treatment evaluation

At the end of the 12-week treatment period, a final evaluation is conducted to determine the change in UACR and other secondary health outcomes.

This evaluation helps in understanding the efficacy of R3R01 compared to the placebo.

Who Can Join the Study?

Adults over 18 years old with type 2 diabetes, which is controlled with a blood test called hemoglobin A1c showing a level below 10.5%.
Women who can have children, and female partners of male participants, must agree not to become pregnant during the study and for 90 days after the last dose of the study medication.
Men, including those who have had a vasectomy, must agree to use condoms if their female partners can have children, from the time they sign the consent form until 90 days after the last dose of the study drug. They must inform the study team if their partner becomes pregnant during the study.
Participants must have a stable treatment for high blood pressure for at least 4 weeks before starting the study drug and throughout the study.
Participants should be on the highest dose they can tolerate of a treatment that blocks certain hormones affecting blood pressure and kidney function.
Participants must have a stable treatment with medications that lower cholesterol.
If participants are taking a type of diabetes medication called SGLT2-Inhibitors, they should be on a stable dose for at least 3 months.
Participants must have a urine test result showing a protein level between 30 mg/g and 5000 mg/g on two separate occasions.
Participants must have a kidney function test result (eGFR) greater than 30 ml/min/1.73 m², which is calculated using a formula called CKD-EPI.
Participants must have abdominal obesity, which means a waist measurement greater than 88 cm for women and greater than 102 cm for men, or a fasting blood fat level (triglycerides) greater than 2.0 mmol/l based on past lab results within 2 years before screening.
Participants must have a systolic blood pressure (the top number) between 110 mmHg and 160 mmHg when measured in a doctor’s office.

Who Cannot Join the Study?

Patients who are not diagnosed with diabetic kidney disease cannot participate. Diabetic kidney disease is a condition where the kidneys are damaged due to diabetes.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Steno Diabetes Center Copenhagen	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.08.2024

Trial locations

Investigated drugs:

R3R01 is a medication being studied for its potential to reduce albuminuria, which is a condition where there is an excess of albumin in the urine. This condition is often associated with diabetic kidney disease. The trial aims to determine if R3R01 can effectively lower the levels of albumin in the urine over a period of 12 weeks.

Diabetic Kidney Disease – This condition is a complication of diabetes that affects the kidneys. It occurs when high blood sugar levels damage the blood vessels in the kidneys, leading to impaired kidney function. Over time, the kidneys may become less effective at filtering waste and excess fluids from the blood. This can result in the buildup of waste products in the body and increased levels of protein in the urine. The progression of the disease can lead to chronic kidney disease if not managed properly. It is important for individuals with diabetes to monitor their kidney health regularly.

Trial ID:

2024-511484-29-00

Protocol code:

R3R01-DKD-201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of R3R01 on Reducing Protein in Urine for Patients with Diabetic Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?