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Study of the effect of empagliflozin on protein levels in the urine for patients with type 2 diabetes and kidney disease.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Type 2 diabetes and renal impairment, which is a condition where the kidneys do not function as well as they should. Specifically, the research looks at patients with a low eGFR, a measurement used to determine how well the kidneys are filtering waste from the blood. The investigation aims to evaluate the effects of empagliflozin on reducing proteinuria, a condition where abnormal amounts of protein are found in the urine, which can be a sign of kidney damage.

Participants in the study will be assigned to receive either empagliflozin or a placebo. The treatment involves taking a 10 mg film-coated tablet once daily. During the study, various factors such as body weight, blood pressure, and levels of substances like sodium, potassium, and bicarbonate in the blood and urine will be monitored. Additionally, the HbA1C, which is a measure of average blood sugar levels over time, will be tracked throughout the process.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    The participation begins with the administration of either jardiance 10 mg, which is a film-coated tablet taken orally once per day, or a placebo, which is a substance that looks identical to the medication but contains no active ingredient.

    The treatment period is organized into several 6-week cycles.

  2. Step 2

    Urine and blood monitoring

    Morning urine samples are collected during two consecutive days at the start of the study and again during two consecutive days at the end of every 6-week period to measure protein levels in the urine.

    For certain assessments, urine collections are required for 3 consecutive days at the beginning of the study and again for 3 days after starting each treatment period to measure sodium and urine volume.

    blood tests are performed every week during each 6-week treatment period to monitor levels of potassium and bicarbonate (a substance that helps maintain the correct acid-base balance in the blood).

  3. Step 3

    Health and physical assessments

    Measurements of body weight are taken at the beginning and at the end of each 6-week period.

    blood pressure is monitored through ambulatory systolic blood pressure readings, which involve continuous monitoring over 3 days at the beginning and at the end of each 6-week period.

    Blood tests are used to monitor hba1c, which is a measure of average blood sugar levels, at the beginning and at the end of each 6-week period.

    The occurrence of any adverse events, which are unexpected or unwanted medical symptoms, is recorded throughout the process.

Who can join the trial?

9 criteria

  • You must have type 2 diabetes, which is a long-term condition that affects how your body processes blood sugar.
  • You must be between 18 and 80 years old.
  • You must be taking a specific type of medicine called RAS blockade (medication that affects the renin-angiotensin system, which helps control blood pressure) at the highest dose you can handle for at least one month.
  • Your eGFR, which is a measure used to show how well your kidneys are filtering waste from your blood, must be between 10 and 20 ml/min/1.73m2.
  • Your UACR (a test that measures the amount of albumin, a type of protein, in your urine) must be greater than 300mg/g.
  • Your UPCR (a test that measures the total amount of protein in your urine) must be greater than 500mg/g.
  • Your systolic blood pressure (the top number in a blood pressure reading) must be higher than 110 mmHg when measured in a doctor's office.
  • You must have been taking a steady dose of antihypertensive drugs (medicines used to lower high blood pressure) and diuretics (medicines that help your body get rid of extra water and salt) for at least one month.
  • Women who are able to become pregnant must have used a reliable form of contraception (birth control, such as pills, implants, or devices) for more than one month before joining the study, and a pregnancy test will be required.

Who cannot join the trial?

11 criteria

  • If the doctor decides that you have a medical condition that makes it unsafe or unwise for you to join the study.
  • If you have experienced any treatment emergent adverse events (unexpected side effects that happen while taking a medicine) or serious adverse events (severe health problems caused by a treatment).
  • If you have a history of ketoacidosis, which is a dangerous buildup of acid in the blood, while taking empagliflozin or other drugs in the SGLT2i class (a specific group of diabetes medicines).
  • If you have taken an investigational medicinal product (a new medicine being tested) as part of another study in the month before your screening.
  • If you have a known hypersensitivity (an allergic reaction) or intolerance (an inability to properly digest or handle a substance) to empagliflozin or any of its excipients (the inactive ingredients used to make the medicine).
  • If the doctor believes you are unlikely to follow the study rules, restrictions, or requirements.
  • If you do not have social insurance (government-provided health coverage).
  • If you are unwilling to provide informed consent (a formal agreement to participate after understanding all risks and benefits).
  • If you belong to a vulnerable group, such as minors, adults under legal guardianship, pregnant women, persons deprived of their liberty, or persons unable to speak French.
  • If there are changes in your serum bicarbonate levels, which is a measure of certain salts in your blood that help maintain your body's acid balance, between the start of the study and each weekly check during the 6-week treatment period.
  • If there are changes in your HbA1C, which is a blood test that shows your average blood sugar levels over the past few months, between the start of the study and the end of each 6-week treatment period.
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Investigated drugs

Jardiance is a medication used to treat patients with type 2 diabetes. It works by helping the kidneys remove excess sugar from the body through urine, which can help protect the kidneys from damage and reduce the amount of protein leaked into the urine.

What is already known about the treatment

Empagliflozin - This medication is taken as a pill by mouth and is widely used to manage type 2 diabetes. It belongs to a group of drugs called SGLT2 inhibitors, which work by preventing the kidneys from reabsorbing sugar back into the blood, allowing the excess sugar to be removed through urine. This process helps lower blood sugar levels and can also help protect the kidneys from damage in patients with diabetes.

Investigated diseases

Type 2 diabetes - This is a chronic condition that affects how the body processes blood sugar. It occurs when the body either resists the effects of insulin or does not produce enough of it to maintain normal glucose levels. Over time, high blood sugar can lead to various complications throughout the body. The condition typically progresses as insulin sensitivity decreases and pancreatic function changes. Renal impairment - This condition refers to a decrease in the ability of the kidneys to filter waste products from the blood. It can be caused by various factors, including long-term high blood sugar levels. As the kidneys lose function, they become less efficient at maintaining fluid and electrolyte balance. The impairment can gradually worsen, leading to a reduction in the kidney's filtration rate.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522119-41-00Estimated enrolment34 patientsSponsorCentre Hospitalier Universitaire De Nice

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