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Focal segmental glomerulosclerosis – Trials in Disease

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Ongoing Clinical Trials for Focal Segmental Glomerulosclerosis

There are currently 7 clinical trials ongoing for Focal Segmental Glomerulosclerosis (FSGS), a kidney disorder that affects the filtering units of the kidneys. These studies are testing various medications including Sparsentan, DMX-200, Frexalimab, Atacicept, and others across multiple European countries. The trials aim to reduce protein levels in urine and protect kidney function in patients with this condition.

Clinical trial locations

Study on Frexalimab, SAR442970, and Rilzabrutinib for Patients Aged 16-75 with Focal Segmental Glomerulosclerosis or Minimal Change Disease

This clinical trial is evaluating three different medications for patients with Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease, two conditions that affect the kidneys’ ability to filter waste properly.

Inclusion criteria: To participate, patients must be between 16 and 75 years old and have a confirmed diagnosis of primary FSGS or Minimal Change Disease through biopsy or genetic testing. They need to have a urine protein-to-creatinine ratio of 3 grams per gram or higher and an estimated glomerular filtration rate of at least 45 mL/min/1.73 m² at screening. Participants should have previously responded to corticosteroid or other immune-suppressing treatments with at least a 40% reduction in protein levels. They must be taking 10 mg per day or less of prednisone or equivalent medication, with this dose remaining stable for at least one week before joining the study. Patients should weigh between 45 and 120 kilograms.

Exclusion criteria: Patients with immune system diseases or those outside the specified age range cannot participate. The study is designed for specific clinical trial groups and includes both male and female participants, but excludes those considered part of vulnerable populations who may be unable to give proper consent.

Study focus: The trial aims to see how well these three treatments can reduce protein levels in urine, which is a key indicator of kidney damage. Participants will be randomly assigned to receive either Frexalimab (given as an intravenous injection), SAR442970 (given as a subcutaneous injection), Rilzabrutinib (taken as an oral tablet), or a placebo. Regular monitoring will track protein levels in urine and any side effects throughout the treatment period.

Investigational drugs: Frexalimab, SAR442970, and Rilzabrutinib are all being tested for their ability to reduce protein leakage in the urine. Frexalimab and SAR442970 work by modulating immune system pathways to reduce inflammation, while Rilzabrutinib is a Bruton’s tyrosine kinase inhibitor that helps control immune system activity.

Study on the Effectiveness and Safety of DMX-200 with Losartan in Adults with Focal Segmental Glomerulosclerosis

This trial is studying a treatment called DMX-200, which contains the active substance Repagermanium, for patients with Focal Segmental Glomerulosclerosis who are already taking medication known as an Angiotensin II Receptor Blocker.

Inclusion criteria: Participants must have been diagnosed with FSGS within the last 7 years, confirmed by kidney biopsy unless there is a known genetic mutation related to the condition. They must be taking an Angiotensin Receptor Blocker at the highest tolerable dose, or be willing to switch to this treatment before the study begins. If taking corticosteroids, the dose must be 10 mg or less per day and stable for at least 4 weeks. Patients must have a urine protein-creatinine ratio greater than 1.5 g/g or 24-hour total protein greater than 1.5 g/day, and an estimated glomerular filtration rate between 25 and 120 mL/min/1.73 m² for adults. Blood pressure must be 160/100 mm Hg or lower, and patients must weigh at least 35 kg with a BMI of 40 kg/m² or lower.

Exclusion criteria: Only adults aged 18 or older with a confirmed FSGS diagnosis who are receiving an ARB can participate.

Study focus: The study will assess how well DMX-200 works in improving kidney function and its safety over a treatment period lasting up to 104 weeks. Participants will be randomly assigned to receive either DMX-200 or a placebo, with regular check-ups to monitor kidney function and overall health. After the double-blind period, there may be an open-label extension where all patients receive DMX-200.

Investigational drug: DMX-200 is being tested to see if it can improve kidney health by reducing the amount of protein in the urine and slowing down the decline in kidney function when used alongside an angiotensin II receptor blocker.

Study on the Safety and Effects of Sparsentan for Children with Proteinuric Kidney Diseases

This study focuses on evaluating the safety and effectiveness of Sparsentan in children with various kidney diseases that cause high levels of protein in the urine, including Focal Segmental Glomerulosclerosis, Minimal Change Disease, IgA Nephropathy, IgA Vasculitis, and Alport Syndrome.

Inclusion criteria: Participants must have signed consent from a parent or legal guardian, and children who can understand must also provide their agreement. They must have an estimated glomerular filtration rate of at least 30 mL/min/1.73 m² and blood pressure within the normal range for their age, sex, and height. For Population 1, children must be at least 1 year old but younger than 18, with a urine protein-creatinine ratio of at least 1.5 g/g at screening, and have specific biopsy findings or genetic mutations related to certain kidney diseases. For Population 2, children must be at least 2 years old but younger than 18, with a urine protein-creatinine ratio of 0.6 g/g or less at screening and confirmed diagnosis through biopsy or genetic testing.

Exclusion criteria: Patients with other serious health conditions that might interfere with the study, those who are pregnant or breastfeeding, those who have had recent major surgery, or those currently participating in another clinical trial cannot participate. Additional exclusions include drug or alcohol abuse, allergies to the study medication, uncontrolled high blood pressure, severe liver or kidney disease, and inability to follow study procedures.

Study focus: The trial will evaluate how safe and well-tolerated Sparsentan is for children with these kidney conditions and monitor how it affects protein levels in their urine over a 108-week period. Researchers will track complete or partial remission of symptoms and any side effects.

Investigational drug: Sparsentan is given as an oral suspension once daily and works by blocking specific receptors in the body to help reduce protein loss in urine.

Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases

This trial tests a medication called atacicept in people with Multiple Autoimmune Glomerular Diseases, including IgA Nephropathy, Membranous Nephropathy, Minimal Change Disease, and Focal Segmental Glomerulosclerosis.

Inclusion criteria: Participants must be receiving stable standard care treatment according to local guidelines and weigh at least 40 kilograms. For adults, systolic blood pressure must be 160 mmHg or lower and diastolic blood pressure must be 90 mmHg or lower. For participants aged 10-17, blood pressure must be below the 95th percentile for their age, gender, and height. Disease-specific requirements vary: IgAN patients need biopsy confirmation and protein levels between 0.5 and 5 g/g creatinine with adequate kidney function; Membranous Nephropathy patients must be 18 or older with biopsy confirmation and specific antibodies present; MCD or FSGS patients need biopsy-confirmed diagnosis with protein in urine of at least 1.0 g/g creatinine.

Exclusion criteria: Patients below 18 or above 75 years old cannot participate. Other exclusions include severe allergic reactions to atacicept, pregnancy or breastfeeding, severe kidney dysfunction, active infections, recent cancer history, major recent surgery, uncontrolled high blood pressure, severe heart disease, active liver disease, recent use of other investigational drugs, and drug or alcohol abuse.

Study focus: The study evaluates how safe atacicept is and how well it works in reducing protein in the urine over 52 weeks. Participants receive atacicept through subcutaneous injection while continuing their regular medications, with regular monitoring of kidney function and disease markers.

Investigational drug: Atacicept is a biological medication that targets specific proteins involved in B-cell development and autoimmune responses, potentially helping to decrease protein leakage into urine in patients with autoimmune kidney disorders.

Study of BI 764198 for Patients with Focal Segmental Glomerulosclerosis

This clinical study evaluates whether a new drug, BI 764198, can help reduce the amount of protein in the urine of patients with Focal Segmental Glomerulosclerosis.

Inclusion criteria: Participants must be between 18 and 75 years old and provide signed informed consent. They must have been diagnosed with FSGS, confirmed by biopsy or having a specific gene mutation known to cause the condition. The urine protein-creatinine ratio must be 1000 mg/g or higher. If taking corticosteroids, the dose must be stable for at least 4 weeks before the study and remain unchanged during it. Similar stability is required for ACE inhibitors, ARBs, finerenone, aldosterone inhibitors, or SGLT2 inhibitors. Body Mass Index should be 40 or less. Women who can have children must agree to use highly effective birth control methods.

Exclusion criteria: Pregnant or breastfeeding women cannot participate. Other exclusions include severe allergic reactions to the study medication, uncontrolled high blood pressure, severe liver disease, drug or alcohol abuse in the past year, current participation in another trial, cancer history in the past five years (with certain exceptions), severe heart disease, history of kidney transplant, and active infections requiring treatment.

Study focus: The study involves taking BI 764198 as an oral capsule once daily for 12 weeks, with some participants receiving a placebo for comparison. Scientists will monitor effectiveness, safety, and tolerance, aiming to determine if BI 764198 can reduce proteinuria. Regular assessments will track the 24-hour urine protein-creatinine ratio and measure blood concentrations of the drug.

Investigational drug: BI 764198 is being studied for its potential to reduce protein levels in the urine by modulating specific pathways affecting kidney function.

Study on R3R01 for Patients with Alport Syndrome and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis

This trial studies a medication called R3R01 for patients with Alport Syndrome and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis.

Inclusion criteria: All patients must be able to communicate well with the study team and provide signed informed consent. For children, parents or legal guardians must sign permission forms, and children who understand must also agree. COVID-vaccinated patients must wait at least one week after their second or booster shot before the first study visit. Patients must have an estimated glomerular filtration rate of at least 45 mL/min/1.73m² and be on stable doses of ACE inhibitors or ARBs for at least 4 weeks. For Alport Syndrome patients, diagnosis must be confirmed through genetic testing or kidney biopsy, with a urine protein-to-creatinine ratio of at least 1.0 g/g. For FSGS patients, they must have primary FSGS confirmed by biopsy or genetic mutation, be steroid-resistant, have a urine protein-to-creatinine ratio between 3.5 and 12.0 g/g, and an estimated glomerular filtration rate greater than 45 mL/min/1.73m².

Exclusion criteria: Patients not diagnosed with either Alport Syndrome or Primary Steroid-Resistant FSGS cannot participate. Other exclusions include being outside the specified age range, inability to take oral medication, other interfering medical conditions, pregnancy or breastfeeding, current participation in another trial, history of allergic reactions to the study medication, and inability to follow study procedures.

Study focus: The study evaluates the safety and tolerability of R3R01 taken orally as a tablet for 12 weeks, as well as its effectiveness in reducing proteinuria. Monitoring includes regular check-ups to assess safety, kidney function changes, quality of life, and how the body processes the medication.

Investigational drug: R3R01 is being tested for its potential to help patients with these kidney conditions by reducing excess protein in the urine.

Study on the Effects of Sparsentan and Irbesartan for Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)

This trial studies the effects of Sparsentan on kidney protection in patients with Focal Segmental Glomerulosclerosis, comparing it to Irbesartan, a medication commonly used to treat high blood pressure and kidney problems.

Inclusion criteria: Patients must have a confirmed diagnosis of FSGS through past biopsy or genetic testing showing a mutation in a specific kidney cell protein. They must be between 18 and 75 years old and weigh at least 20 kg at screening (patients under 18 may be included only in the United States and United Kingdom). A urine protein-to-creatinine ratio of at least 1.5 g/g and an estimated glomerular filtration rate of at least 30 mL/min/1.73 m² at screening are required. Average seated blood pressure must be between 100/60 mmHg and 160/100 mmHg. Women of childbearing potential must agree to use contraception and undergo pregnancy testing. For the open-label extension period, patients must have completed the double-blind period including the Week 112 visit.

Exclusion criteria: Patients without an FSGS diagnosis or outside the specified age range cannot participate. Other exclusions include unwillingness to follow study procedures, interfering medical conditions or medications, pregnancy or breastfeeding, drug or alcohol abuse history, recent participation in another trial, allergies to study medication, and history of non-compliance with medical treatments.

Study focus: The study is designed as a double-blind trial where participants receive either Sparsentan or Irbesartan in tablet form by mouth, with monitoring over approximately two years to compare kidney function and protein levels in urine. An open-label extension phase follows where all participants receive Sparsentan to assess long-term effects.

Investigational drug: Sparsentan works by blocking two types of receptors in the body—endothelin receptors and angiotensin receptors—which is thought to help reduce kidney damage and improve kidney function over time.

Summary

The 7 ongoing clinical trials for Focal Segmental Glomerulosclerosis represent a diverse range of therapeutic approaches to treating this challenging kidney disorder. Geographically, the trials show the strongest presence in Germany, France, Spain, and Italy, each hosting six or more studies, reflecting these countries’ significant involvement in nephrology research. Belgium and Poland also demonstrate notable engagement with four trials each.

The investigational drugs being tested include Sparsentan, which appears in multiple trials and works by blocking both endothelin and angiotensin receptors; DMX-200, containing Repagermanium; Frexalimab and SAR442970, which are immunomodulatory agents; Rilzabrutinib, a Bruton’s tyrosine kinase inhibitor; Atacicept, which targets B-cell function; BI 764198; and R3R01. All these medications share a common goal of reducing proteinuria, the excess protein in urine that is a hallmark of kidney damage in FSGS.

The trials vary in their target populations, with some focusing specifically on adult patients, others on children, and some including both age groups. Several studies also include patients with related conditions such as Minimal Change Disease and Alport Syndrome, recognizing the overlap in pathophysiology and potential treatments. Treatment durations range from 12 weeks to over 2 years, reflecting both short-term safety assessments and long-term efficacy evaluations. Most trials employ double-blind, placebo-controlled designs to ensure rigorous scientific evaluation of the investigational medications.

Ongoing Clinical Trials on Focal segmental glomerulosclerosis

  • A study to evaluate the effects of BI 764198 in adults and adolescents with focal segmental glomerulosclerosis (FSGS)

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia Denmark France Germany Greece +9

  • Study on Frexalimab, SAR442970, and Rilzabrutinib for Patients Aged 16-75 with Focal Segmental Glomerulosclerosis or Minimal Change Disease

    Recruiting

    1
    Investigated diseases:
    Czechia France Germany Greece Hungary Italy +5

  • Study on the Safety and Effects of Sparsentan for Children with Proteinuric Kidney Diseases

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy The Netherlands Poland Spain Sweden

  • Study on the Effects of Sparsentan and Irbesartan for Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia Czechia Denmark Estonia France +6

  • Study of BI 764198 for Patients with Focal Segmental Glomerulosclerosis

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Spain

  • Study on R3R01 for Patients with Alport Syndrome and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany The Netherlands

  • Study on the Effectiveness and Safety of DMX-200 with Losartan in Adults with Focal Segmental Glomerulosclerosis

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Italy Portugal +1

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