Ongoing Clinical Trials for Proteinuria
There are currently 3 ongoing clinical trials investigating treatments for proteinuria, a condition where excess protein appears in the urine, often indicating kidney damage. These studies are exploring medications that may help protect kidney function in children and adults with chronic kidney disease and proteinuria. The trials are being conducted across multiple European countries and focus on evaluating the safety and effectiveness of treatments used alongside standard blood pressure medications.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Study on Finerenone for Children with Chronic Kidney Disease and Proteinuria Using ACEI or ARB
- Study on the Effects of Camostat Mesilate for Kidney Protection in Patients with Chronic Kidney Disease and Proteinuria
- Study on the Long-Term Safety of Finerenone with ACE Inhibitors or ARBs for Children and Young Adults with Chronic Kidney Disease and Proteinuria
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Lithuania
- Netherlands
- Poland
- Portugal
- Spain
- Sweden
Study on Finerenone for Children with Chronic Kidney Disease and Proteinuria Using ACEI or ARB
This study is investigating whether adding a medication called finerenone to standard treatment can help reduce protein levels in the urine of children with chronic kidney disease. The trial is for children aged 6 months to under 18 years who are already taking blood pressure medications known as ACE inhibitors or ARBs.
Who can join: Children must have chronic kidney disease with specific kidney function levels, depending on their age. For those aged 1 to under 18 years, their kidneys should be working at 30% or more of normal function. The child must also have high protein levels in their urine, measured by a test called the urinary protein-to-creatinine ratio. They should already be taking an ACE inhibitor or ARB at the highest tolerable dose for at least 30 days before starting the study. Blood potassium levels must be within safe ranges, and kidney function should remain stable during the screening period.
Who cannot join: Children who have conditions other than chronic kidney disease and proteinuria are not eligible for this study.
What the study involves: The main goal is to see if finerenone, when added to existing treatment, can reduce the amount of protein in the urine more effectively than a placebo. Participants will take either finerenone or a placebo for six months. The medication comes as tablets or granules that can be mixed with liquid, depending on the child’s age and size. Throughout the study, doctors will monitor kidney function, blood pressure, protein levels in urine, and watch for any side effects.
Medications being tested: The study uses finerenone, a medication that blocks certain hormones that can damage the kidneys. It is taken alongside ACE inhibitors or ARBs, which are standard treatments that help relax blood vessels and lower blood pressure.
Study on the Effects of Camostat Mesilate for Kidney Protection in Patients with Chronic Kidney Disease and Proteinuria
This study is examining how a medication called camostat mesilate affects the body’s handling of salt and water in adults with chronic kidney disease and proteinuria. The research aims to understand whether this medication can help protect kidney function.
Who can join: Adults over 18 years old with chronic kidney disease can participate. Their kidneys must be working at more than 30% of normal function, measured by a test called eGFR. They must also have high protein levels in their urine, with a measurement greater than 300 mg/g. Participants need to have stable blood pressure treatment for at least two weeks before joining and their blood pressure should be between 120/70 and 150/90 mmHg. Women who can become pregnant must have a negative pregnancy test and use birth control during the study and for one week after.
Who cannot join: People with other serious health conditions that could interfere with the study, those who are pregnant or breastfeeding, anyone with a known allergy to camostat mesilate, and those who participated in another trial within the last 30 days cannot join. People with a history of drug or alcohol abuse in the past year, uncontrolled high blood pressure, severe liver disease, or a recent heart attack or stroke are also excluded. Those taking medications that might interfere with the study drug cannot participate.
What the study involves: The study will measure how camostat mesilate affects urine sodium and water excretion, body weight, blood pressure, and other markers in blood and urine that show how the kidneys are working. Participants will take the medication as tablets and continue their regular blood pressure treatment. Researchers will compare results with healthy individuals to understand the medication’s effects.
Medications being tested: Camostat mesilate is a protease inhibitor that blocks certain enzymes which may contribute to kidney damage. The goal is to see if it can help protect kidney function by affecting how the body manages salt and water.
Study on the Long-Term Safety of Finerenone with ACE Inhibitors or ARBs for Children and Young Adults with Chronic Kidney Disease and Proteinuria
This is a long-term safety study of finerenone for children and young adults aged 1 to 18 years who have chronic kidney disease and proteinuria. The study follows participants who previously completed another finerenone study called FIONA.
Who can join: Participants must be between 1 and 18 years old and have previously taken part in the FIONA study without being permanently stopped from treatment. They must have chronic kidney disease with kidneys working at 30% or more of normal function. Participants must be taking an ACE inhibitor or ARB at the highest dose they can handle, with no changes to this treatment for at least 30 days before joining. Blood potassium levels must be within safe ranges. Children must be able to receive food normally, through bottle or cup feeding, or through feeding tubes.
Who cannot join: Children without chronic kidney disease and proteinuria, those outside the specified age range, and those unable to take ACE inhibitors or ARBs cannot join. Children with other medical conditions that might interfere with the study or who cannot follow study procedures are also excluded.
What the study involves: The main goal is to monitor the long-term safety of using finerenone alongside ACE inhibitors or ARBs over 18 months. Participants will take finerenone as tablets or granules, with doses adjusted based on age and body weight. Researchers will watch for any side effects and monitor changes in blood pressure, potassium levels, protein in urine, and kidney function throughout the study.
Medications being tested: The study uses finerenone, a non-steroidal mineralocorticoid receptor antagonist that blocks the effects of aldosterone, a hormone that can damage kidneys. It is used together with ACE inhibitors or ARBs, which are standard treatments for managing blood pressure and protecting kidney function.
Summary
All three ongoing clinical trials focus on protecting kidney function in patients with proteinuria. Two of the studies specifically target children and young adults with finerenone, while one focuses on adults with camostat mesilate. The research is concentrated across multiple European countries, with Denmark participating in all three trials.
A notable pattern is the strong emphasis on finerenone as a potential treatment option. Two separate studies are examining this medication in pediatric populations—one evaluating its effectiveness over six months and another assessing its long-term safety over 18 months. These studies build on each other, with the safety study following participants from the earlier FIONA trial.
All trials require participants to continue their existing treatment with ACE inhibitors or ARBs, which are standard medications for managing kidney disease. This approach tests whether adding new medications can provide additional benefits beyond current standard care. The trials also share a common focus on monitoring kidney function, protein levels in urine, blood pressure, and potassium levels as key safety and effectiveness measures.
The geographic distribution shows strong participation from Western and Northern European countries, with all three studies available across 16 different nations. This wide availability may provide more opportunities for eligible patients to participate in research that could advance treatment options for proteinuria and chronic kidney disease.
