Ongoing Clinical Trials for Glomerulonephritis Minimal Lesion
Two clinical trials are currently investigating new treatments for glomerulonephritis minimal lesion (also known as minimal change disease). These studies are testing different investigational medications to help reduce protein levels in urine and improve kidney function in both adults and children with this condition.
Clinical trial locations
- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Portugal
- Slovakia
- Spain
- Sweden
Study on Frexalimab, SAR442970, and Rilzabrutinib for Patients Aged 16-75 with Focal Segmental Glomerulosclerosis or Minimal Change Disease
This study is evaluating three different investigational medications for adults and adolescents with minimal change disease or focal segmental glomerulosclerosis. The trial aims to determine which treatment is most effective at reducing protein levels in the urine, a key sign of kidney damage in these conditions.
Main inclusion criteria: To participate, patients must be between 16 and 75 years old with a biopsy-confirmed diagnosis of primary minimal change disease or focal segmental glomerulosclerosis. They must have significant protein in their urine, with a urine protein to creatinine ratio of at least 3 grams per gram at screening. Kidney function must be reasonably preserved, with an estimated glomerular filtration rate of at least 45 milliliters per minute per 1.73 square meters. Patients must also have previously responded to corticosteroid or other immunosuppressive therapy by showing at least a 40% reduction in protein levels when their pre-treatment levels were 3.5 grams per gram or higher. At the time of joining the study, participants should be taking a stable, low dose of prednisone or equivalent medication (10 milligrams per day or less) for at least one week. Body weight must be between 45 and 120 kilograms.
Main exclusion criteria: The study cannot include patients with other immune system diseases that might interfere with the trial. Participants must fall within the specified age range and be male or female. Those considered part of vulnerable populations who cannot provide proper consent are excluded.
Focus and goals: The primary goal is to measure how effectively each medication reduces protein levels in the urine over the course of the study. Participants will be randomly assigned to receive one of three investigational treatments or a placebo, and neither the participants nor the researchers will know who is receiving which treatment to ensure unbiased results. Regular monitoring will track changes in urine protein levels and kidney function, as well as any side effects.
Investigational drugs: The study is testing three medications:
- Frexalimab is given as an intravenous injection through a vein. It works by targeting specific pathways in the immune system to reduce inflammation and protein loss in the urine.
- SAR442970 is administered as a subcutaneous injection under the skin. Like frexalimab, it modulates immune responses to decrease inflammation and proteinuria.
- Rilzabrutinib is taken orally as a tablet. It is a Bruton’s tyrosine kinase inhibitor that helps control immune system activity by inhibiting specific enzymes involved in inflammation.
Study on the Safety and Effects of Sparsentan for Children with Proteinuric Kidney Diseases
This clinical trial is studying a medication called sparsentan for children with various kidney diseases that cause high levels of protein in the urine, including minimal change disease, focal segmental glomerulosclerosis, and other proteinuric glomerular diseases. The study will assess both the safety and effectiveness of sparsentan over a 108-week treatment period.
Main inclusion criteria: The study is enrolling children and adolescents in two different groups. For the first population, participants must be between 1 and 17 years old with a urine protein to creatinine ratio of at least 1.5 grams per gram at screening. They must have a kidney biopsy showing specific patterns related to their kidney disease or documented genetic mutations associated with these conditions. For the second population, children between 2 and 17 years old with a urine protein to creatinine ratio of 0.6 grams per gram or less at screening can participate if they have a confirmed diagnosis through biopsy or genetic testing. All participants must have an estimated glomerular filtration rate of at least 30 milliliters per minute per 1.73 square meters and normal blood pressure for their age and height. Written consent from a parent or legal guardian and the child’s agreement to participate are required.
Main exclusion criteria: Children cannot participate if they have other serious health conditions that might interfere with the study, are pregnant or breastfeeding, have had recent major surgery, are currently in another clinical trial, have a history of drug or alcohol abuse, are allergic to the study medication, have uncontrolled high blood pressure, have severe liver or kidney disease beyond what the study is treating, are unable to follow study procedures, or have a history of certain heart conditions.
Focus and goals: The primary aim is to evaluate how safe sparsentan is for children with these kidney diseases and to measure changes in protein levels in their urine over the 108-week study period. Researchers will also monitor how the body processes the medication and track how many participants experience complete or partial remission of their symptoms, such as significant reductions in protein loss. Any side effects will be carefully documented to determine the overall safety profile of sparsentan in children.
Investigational drug: Sparsentan is given as an oral suspension, taken once daily. It works by blocking specific receptors in the body, including angiotensin receptors and endothelin receptors, which helps reduce protein loss in urine and may improve kidney function. The medication is classified as both an angiotensin receptor blocker and endothelin receptor antagonist.
Summary
Two clinical trials are currently available for patients with minimal change disease, offering opportunities for both adults and children to access investigational treatments. The adult trial is particularly extensive, taking place across 11 European countries including Slovakia, Portugal, Greece, Poland, Spain, Netherlands, Czechia, Germany, Italy, France, and Hungary. This study takes a comprehensive approach by testing three different medications simultaneously to determine which may be most effective.
The pediatric trial is being conducted in six European countries: Sweden, Germany, Italy, Netherlands, Poland, and Spain. This study focuses specifically on children and uses a single investigational medication over a longer treatment period of 108 weeks.
Both trials share a common goal of reducing protein levels in urine, which is a key indicator of kidney damage in these conditions. The availability of trials for different age groups reflects the medical community’s recognition that minimal change disease affects both children and adults, often requiring different treatment approaches. Patients interested in participating should discuss these options with their kidney specialist to determine which trial, if any, might be appropriate for their specific situation.
