Clinical Trials for Diabetic Nephropathy
There are currently 5 ongoing clinical trials investigating new treatments for diabetic nephropathy, a kidney complication of diabetes. These studies are testing medications like empagliflozin, finerenone, and other investigational drugs to reduce protein in the urine and protect kidney function. Trials are taking place across Europe, including Denmark, the Netherlands, Belgium, Germany, Spain, Italy, and France. (Also known as: Diabetic Kidney Disease, Albuminuria in Diabetes)
Clinical trial locations
- Belgium
- Denmark
- Study on Aspirin’s Effect on Platelet Aggregation in Patients with Type 1 Diabetes, Atherosclerotic Cardiovascular Disease, and Diabetic Kidney Disease
- Study on Hyperpolarized [1-13C]Pyruvate and Meglumine Gadoterate for Patients with Diabetic Kidney Disease
- Study on the Effectiveness and Safety of Finerenone and Empagliflozin in Adults with Chronic Kidney Disease and Type 2 Diabetes
- Study on the Effects of R3R01 on Reducing Protein in Urine for Patients with Diabetic Kidney Disease
- France
- Germany
- Italy
- Netherlands
- Spain
Remote Study on Empagliflozin and Finerenone for Reducing Kidney Issues in Type 2 Diabetes Patients
This innovative trial is conducted entirely remotely, allowing participants to take part from home using digital technologies. It focuses on people with type 2 diabetes who have albuminuria, meaning excessive protein in their urine, which signals kidney damage.
Main inclusion criteria: Participants must be at least 18 years old with type 2 diabetes and have a urinary albumin-to-creatinine ratio between 4.5 and 300 mg/mmol. Their estimated glomerular filtration rate, which measures how well the kidneys filter blood, must be at least 25 mL/min/1.73m². Participants should also be on a stable dose of ACE inhibitors or ARBs (blood pressure medications that also protect the kidneys) and be proficient in Dutch.
Main exclusion criteria: People without type 2 diabetes or albuminuria, or those outside the specified age range, cannot participate. The study includes both men and women and does not exclude vulnerable populations.
Trial focus: The study aims to evaluate how well empagliflozin and finerenone, used alone or together, can improve kidney health. Researchers will monitor changes in kidney function, blood pressure, and blood sugar levels. The remote format allows participants to provide urine samples and monitor their health metrics from home, making participation more convenient while gathering data on the feasibility of conducting kidney disease trials remotely.
Investigational drugs: Empagliflozin (Jardiance) is a medication that helps control blood sugar by encouraging the kidneys to remove glucose through urine. Finerenone (Kerendia) protects the kidneys by blocking certain hormones that cause inflammation and scarring. The trial tests both medications separately and in combination.
Study on Hyperpolarized [1-13C]Pyruvate and Meglumine Gadoterate for Patients with Diabetic Kidney Disease
This diagnostic trial uses advanced imaging techniques to better understand how the kidneys are functioning in people with diabetic kidney disease. It employs a special type of MRI scan with hyperpolarized pyruvate to create clearer images of kidney metabolism and blood flow.
Main inclusion criteria: Participants must be between 18 and 85 years old. For those with type 1 diabetes and kidney disease, their eGFR should be between 15 and 60 ml/min, and their urine albumin-creatinine ratio must exceed 100 mg/g. Those with type 1 diabetes but without kidney disease must have an eGFR above 60 ml/min and no albumin in their urine. Control subjects without diabetes need an eGFR above 60 ml/min. Pre-menopausal women must not be pregnant.
Main exclusion criteria: People with other serious health conditions, pregnant or breastfeeding women, those with recent participation in other trials, history of allergic reactions to study substances, or inability to undergo MRI scans (due to metal implants or severe claustrophobia) cannot participate. Those unable to provide informed consent are also excluded.
Trial focus: The study aims to evaluate whether this advanced imaging method can help classify the progression of kidney disease in diabetes. Researchers will assess kidney metabolism, blood flow, and function by measuring the urine albumin-to-creatinine ratio and using specialized MRI techniques. The trial continues until August 2029.
Investigational drugs: Hyperpolarized [1-13C]Pyruvate is a specialized imaging agent injected intravenously to enhance MRI images. It allows doctors to visualize kidney metabolism and function more clearly, helping to better understand disease progression.
Study on the Effects of R3R01 on Reducing Protein in Urine for Patients with Diabetic Kidney Disease
This trial tests a new investigational medication called R3R01 to see if it can effectively reduce albumin levels in the urine of people with diabetic kidney disease over a 12-week period.
Main inclusion criteria: Participants must be adults over 18 with type 2 diabetes controlled to a hemoglobin A1c level below 10.5%. They must have been on stable blood pressure treatment for at least 4 weeks and be taking the maximum tolerated dose of ACE inhibitors or ARBs. Their urine protein levels must be between 30 and 5000 mg/g, and their eGFR must exceed 30 ml/min/1.73m². They must also have abdominal obesity or elevated blood fat levels. Both women who can have children and men must agree to use contraception during the study and for 90 days after.
Main exclusion criteria: Those without diabetic kidney disease, people outside the specified age range, and vulnerable populations cannot participate.
Trial focus: The study evaluates whether R3R01 can reduce the urinary albumin-to-creatinine ratio compared to placebo over 12 weeks. Participants are randomly assigned to receive either R3R01 or placebo tablets, with regular monitoring of kidney function, blood pressure, and urine protein levels throughout the study.
Investigational drugs: R3R01 is an oral tablet being studied for its potential to reduce albuminuria. It works by inducing ABCA1 activity, a protein involved in lipid transport and cholesterol balance, which may improve kidney function.
Study on Aspirin’s Effect on Platelet Aggregation in Patients with Type 1 Diabetes, Atherosclerotic Cardiovascular Disease, and Diabetic Kidney Disease
This trial examines how blood platelets behave in people with type 1 diabetes and investigates whether aspirin affects blood clotting differently in these patients, particularly in relation to heart and kidney health.
Main inclusion criteria: Participants must have type 1 diabetes, be over 18 years old, and be capable of providing informed consent. The study includes both men and women.
Main exclusion criteria: The trial excludes people with atherosclerotic cardiovascular disease (narrowed or blocked blood vessels), type 1 diabetes, or diabetic kidney disease from certain study groups. However, these conditions may be inclusion criteria for other parts of the study.
Trial focus: The study investigates how platelets aggregate (clump together) in people with type 1 diabetes before and after aspirin treatment. Researchers examine the relationship between platelet function, the presence of fatty deposits in arteries, and kidney function. Participants take aspirin for at least seven days, and blood tests measure changes in platelet behavior and inflammation markers. The trial aims to predict future cardiovascular outcomes based on these measurements.
Investigational drugs: Acetylsalicylic acid (aspirin) is taken orally as a solution. It works by preventing platelets from clumping together, which can reduce the risk of blood clots. The trial examines how well aspirin works in diabetic patients with different levels of kidney damage.
Study on the Effectiveness and Safety of Finerenone and Empagliflozin in Adults with Chronic Kidney Disease and Type 2 Diabetes
This large international trial compares the effectiveness of using finerenone and empagliflozin together versus using each medication alone in people with chronic kidney disease and type 2 diabetes.
Main inclusion criteria: Participants must have chronic kidney disease and type 2 diabetes with hemoglobin A1c below 11%. Their eGFR should be between 40 and 90 ml/min/1.73m² for Part A, or between 30 and 90 ml/min/1.73m² for Part B. Their urinary albumin-to-creatinine ratio must be between 100 and 5000 mg/g, with documented evidence of protein in the urine at least 3 months before screening. Participants must have been taking the maximum tolerated dose of ACE inhibitors or ARBs for more than a month. The study is open to all genders and includes vulnerable populations.
Main exclusion criteria: People with severe liver disease, recent heart attack or stroke within the last 6 months, uncontrolled high blood pressure, pregnant or breastfeeding women, those with severe allergic reactions to the study drugs, certain types of cancer, severe non-diabetic kidney disease, or current participation in other clinical trials cannot join.
Trial focus: The study evaluates whether combining finerenone and empagliflozin is more effective at reducing the urinary albumin-to-creatinine ratio than either medication alone. Participants are randomly assigned to receive finerenone (10 or 20 mg), empagliflozin (10 mg), or both medications together. The treatment lasts 180 days, with regular monitoring of kidney function and health parameters throughout.
Investigational drugs: Finerenone is a non-steroidal mineralocorticoid receptor antagonist that reduces kidney inflammation and scarring. Empagliflozin is an SGLT2 inhibitor that helps the kidneys remove sugar from the blood through urine while also protecting kidney function. The trial tests whether using both medications together provides better kidney protection than either drug alone.
Summary
These five ongoing clinical trials represent important efforts to improve treatment options for diabetic kidney disease. Denmark hosts the most trials with four studies, while the large international trial spans seven European countries including Belgium, Germany, Spain, Italy, France, and the Netherlands.
A notable pattern is the focus on two main medications: empagliflozin and finerenone. Three trials investigate these drugs either alone or in combination, suggesting that researchers are particularly interested in understanding how these medications can best protect kidney function. One study stands out for its remote format, allowing participants to take part from home, which may make clinical research more accessible to patients.
The trials employ diverse approaches, from testing new investigational drugs like R3R01 to using advanced imaging techniques to better understand kidney function. While most studies focus on type 2 diabetes, one trial specifically examines type 1 diabetes, addressing the need for research in this population. Treatment durations vary from 12 weeks to several years, with the imaging study continuing until 2029.
All studies aim to reduce protein in the urine and slow kidney damage, but they use different methods to measure success and gather evidence. This variety in research approaches helps build a more complete understanding of how to best manage diabetic kidney disease.