Ongoing Clinical Trials for Nephrotic Syndrome
Currently, there are 9 clinical trials investigating new treatments for nephrotic syndrome across multiple European countries. These studies focus on various forms of the condition, including steroid-sensitive, steroid-dependent, and idiopathic forms, testing medications such as Rituximab, Obinutuzumab, Atacicept, and other immunosuppressive therapies. The trials are being conducted in France, Poland, Italy, Netherlands, Denmark, Sweden, Belgium, Spain, and Germany, involving both children and adults.
Clinical trial locations
- Belgium
- Denmark
- France
- Study of Rituximab, Prednisolone and Betamethasone in Adult Patients with First Episode of Minimal Change Nephrotic Syndrome to Prevent Disease Relapse
- Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases
- Study on Obinutuzumab vs. Rituximab for Children with Steroid-Dependent and Frequent Relapsing Nephrotic Syndrome
- Study on the Effectiveness and Safety of Obinutuzumab and Mycophenolate Mofetil in Children with Idiopathic Nephrotic Syndrome
- Germany
- Italy
- Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases
- Study on Rituximab Treatment for Children with Complicated Steroid-Sensitive Nephrotic Syndrome
- Study on the Effectiveness and Safety of Obinutuzumab and Mycophenolate Mofetil in Children with Idiopathic Nephrotic Syndrome
- Netherlands
- Poland
- Study on Early Rituximab Treatment for Children with Nephrotic Syndrome
- Study on the Effectiveness of Ketoanalogues in Preventing Muscle Loss in Patients with Nephrotic Syndrome
- Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases
- Study on the Effectiveness and Safety of Obinutuzumab and Mycophenolate Mofetil in Children with Idiopathic Nephrotic Syndrome
- Spain
- Sweden
Study of Rituximab, Prednisolone and Betamethasone in Adult Patients with First Episode of Minimal Change Nephrotic Syndrome to Prevent Disease Relapse
This study is focused on adults experiencing their first episode of Minimal Change Nephrotic Syndrome. Participants must be at least 18 years old and have either low albumin levels with significant protein in the urine, or a kidney biopsy showing minimal changes. They should be registered with the French healthcare system and able to provide informed consent.
People cannot participate if they are younger than 18 or older than 65, have been previously treated with Rituximab, are pregnant or breastfeeding, have active infections like hepatitis or tuberculosis, have severe heart or liver disease, have had cancer in the past 5 years, or have allergies to the study medications. Those with mental conditions affecting consent or a history of substance abuse in the past year are also excluded.
The main goal of this trial is to test whether Rituximab, given as two infusions one week apart along with a short course of steroids, can prevent the condition from returning. The treatment is followed by a gradual reduction of steroids over 9 weeks, with monitoring continuing for 18 months. Doctors will regularly check protein levels in blood and urine to assess how well the treatment works.
The investigational drug is Rituximab, a medication given through intravenous infusion that targets specific immune system cells called B cells. It is commonly used to treat autoimmune conditions and some blood cancers, but is being studied here as a treatment for Minimal Change Nephrotic Syndrome. Steroids are also used to reduce inflammation and suppress the immune system as part of the initial treatment.
Study on Early Rituximab Treatment for Children with Nephrotic Syndrome
This Polish trial focuses on children with idiopathic nephrotic syndrome. To participate, children or their legal guardians must provide consent. Participants must be between 2 and 16 years old with a diagnosis of idiopathic steroid-dependent nephrotic syndrome or frequently relapsing forms. They must be in remission immediately before entering the study, meaning they have little or no protein in the urine for 3 consecutive days.
The study excludes children with other serious health conditions, those who are pregnant or breastfeeding, participants unable to follow study procedures, those with known allergies to the medication, those with substance abuse history, uncontrolled high blood pressure, severe liver or kidney disease, recent cancer history, or recent heart attack or stroke.
The study aims to assess how long the disease stays in remission in children receiving rituximab compared to those receiving placebo. Participants will be monitored over a year to see how long they remain free from relapses and to evaluate the total amount of steroids needed. This information could help improve treatment strategies for children with this condition.
The investigational drug is Rituximab, administered through intravenous infusion. It targets specific immune system cells that may be causing kidney malfunction, helping to reduce symptoms and potentially leading to longer periods without symptoms.
Study on the Effectiveness of Ketoanalogues in Preventing Muscle Loss in Patients with Nephrotic Syndrome
This Polish study focuses on patients with moderate to very severe nephrotic syndrome experiencing protein-energy wasting. Participants must have albumin levels less than 3.0 g/dL and daily protein loss in urine more than 3.5 g/day. They must be experiencing a new episode, persistent symptoms despite treatment, or relapse after improvement. Previous treatment with certain immune-suppressing drugs is allowed under specific conditions. Participants must have adequate kidney function and be at least 18 years old.
The study excludes patients not experiencing protein-energy wasting, those without moderate to very severe forms of the condition, and those not meeting the age requirements or other study-specific criteria.
The trial tests KETOSTERIL, which contains ketoanalogues of essential amino acids, important building blocks for proteins that may help prevent muscle loss. The study will last up to 12 months, with participants randomly assigned to receive either KETOSTERIL or placebo. The main focus is measuring the maximum loss of lean body mass over six months, along with changes in walking distance, handgrip strength, and blood markers.
The investigational drug is Ketoanalogues of Essential Amino Acids, taken orally as film-coated tablets. These supplements provide building blocks similar to amino acids to help maintain muscle mass in patients experiencing protein-energy wasting.
Study on the Safety and Effects of AP1189 for Patients with Idiopathic Membranous Nephropathy and Severe Proteinuria
This trial, conducted in Denmark and Sweden, studies idiopathic membranous nephropathy with severe protein loss in urine. Participants must be aged 18-85 years with a diagnosis confirmed by specific antibody tests or kidney biopsy. They must have severe proteinuria and adequate kidney function. Participants should be on ACE inhibitors or angiotensin II receptor blockers for at least one month with stable blood pressure, or have discontinued these due to side effects. Women of childbearing potential must use reliable contraception and have negative pregnancy tests.
Exclusions include patients with other kidney diseases, those outside the specified age range, vulnerable populations, pregnant or breastfeeding women, those with conditions or medications that might interfere with study results, recent participants in other trials, those with serious allergic reactions to study medications, and those with conditions making participation unsafe.
The trial tests the AP1189 Tablet containing resomelagon, comparing it to placebo when used alongside standard treatments. The 12-week study monitors participants for side effects and effectiveness in reducing protein loss in urine, checking vital signs, conducting electrocardiograms, and performing laboratory assessments.
The investigational drug is AP1189, taken orally once daily. It works by modulating certain pathways in the body to reduce inflammation and improve kidney function, classified as an anti-inflammatory agent.
Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases
This multi-country trial in Italy, Poland, Belgium, France, Spain, and Germany tests atacicept in people with Multiple Autoimmune Glomerular Diseases, including IgA Nephropathy, Membranous Nephropathy, Minimal Change Disease, and Focal Segmental Glomerulosclerosis. Participants must be on stable standard care treatment with controlled blood pressure and weigh at least 40 kg. Disease-specific requirements include biopsy confirmation and specific protein levels in urine. Those with Membranous Nephropathy must be 18 or older, while children as young as 10 may participate in other categories.
Exclusions include those aged below 18 or above 75 years, people with severe allergies to atacicept, pregnant or breastfeeding women, those with severe kidney dysfunction, active infections, recent cancer history, recent major surgery, uncontrolled high blood pressure, severe heart disease, liver disease, recent use of other investigational drugs, substance abuse history, and mental conditions affecting participation.
The 52-week study evaluates how safe atacicept is and how well it reduces protein in urine. The medication is given as a subcutaneous injection using a pre-filled syringe while participants continue their regular medications. Doctors monitor kidney function, protein levels in urine, and specific disease markers in the blood.
The investigational drug is Atacicept, administered through subcutaneous injection. It targets specific proteins in the immune system to reduce inflammation and control the immune system’s attack on kidney tissues, potentially decreasing proteinuria.
Study of levamisole and prednisolone combination to prevent nephrotic syndrome relapse in children aged 2-16 years with first episode of steroid-sensitive disease
This Dutch study examines children with steroid-sensitive idiopathic nephrotic syndrome. Participants must have responded positively to steroid treatment, weigh more than 9 kg, and be able to swallow a 5 mg tablet. Girls who have reached puberty need negative pregnancy tests. Children must not have neutropenia and their parents must provide written consent. Participants must be between 2 and 16 years old and able to follow all study requirements.
Exclusions include children younger than 2 or older than 16, those allergic to levamisole, those with steroid-resistant forms, previous levamisole treatment, severe kidney impairment, active infections, compromised immune systems, liver disease, participation in other trials, inability to follow protocols, and known genetic causes.
The research examines whether adding levamisole to standard treatment can prevent disease recurrence. The medication, called Elmisol, comes in various strength tablets. The treatment period lasts 24 months, with doctors monitoring relapse frequency and side effects. The dose is calculated based on the patient’s weight.
The investigational drugs are Levamisole, an immune system modulator given alongside corticosteroids to reduce relapse frequency, and Corticosteroids, which reduce inflammation and manage symptoms to achieve initial remission.
Study on Obinutuzumab vs. Rituximab for Children with Steroid-Dependent and Frequent Relapsing Nephrotic Syndrome
This French study compares Obinutuzumab and Rituximab in children with Idiopathic Nephrotic Syndrome. Participants must be between 3 and 18 years old with Steroid Dependent Nephrotic Syndrome or Frequent Relapsing Nephrotic Syndrome. They must have had their last relapse within 3 months and be in remission at randomization. Children must be up-to-date with vaccinations, and parents must provide informed consent.
The study excludes patients with kidney conditions other than Idiopathic Nephrotic Syndrome, those outside the specified age range, and those from vulnerable populations.
The purpose is determining which medication is more effective in preventing relapses over 12 months. Both medications are given through intravenous infusion. Participants are monitored for relapses, duration of medication effects, side effects including infusion reactions and infections. The study assesses cost-effectiveness and antibody development.
The investigational drugs are Obinutuzumab and Rituximab, both given as infusions. They are being tested to see which can better prevent relapses in children with this kidney condition.
Study on Rituximab Treatment for Children with Complicated Steroid-Sensitive Nephrotic Syndrome
This Italian trial focuses on complicated forms of steroid-sensitive nephrotic syndrome in children. Participants or their legal guardians must provide written consent. Eligibility includes children and young adults aged 3 to 24 years with complicated forms of frequently relapsing or steroid-dependent nephrotic syndrome. They must have at least 2 relapses per year while on specific medications. Previous rituximab treatments are allowed. Participants must be able to communicate effectively with the medical team. Women of childbearing potential must use reliable birth control throughout the study.
Exclusions include those with other serious health conditions, past allergic reactions to study medications, current participation in other trials, pregnancy or breastfeeding, substance abuse history, recent use of certain medications, compromised immune systems, recent infections requiring antibiotics, cancer history, and recent major surgery.
The study uses Rixathon containing rituximab, comparing two treatment plans to determine the best approach. The 24-month study monitors relapse numbers, hospitalization days, severe infections, and various blood markers including immunoglobulin levels.
The investigational drug is Rixathon, a concentrate for intravenous infusion. It is a monoclonal antibody targeting specific immune system cells to help manage the kidney condition by reducing relapse frequency.
Study on the Effectiveness and Safety of Obinutuzumab and Mycophenolate Mofetil in Children with Idiopathic Nephrotic Syndrome
This multi-country trial in Belgium, Italy, Spain, Poland, Germany, and France studies Childhood Idiopathic Nephrotic Syndrome. Participants must have been diagnosed with frequently relapsing or steroid-dependent forms before age 18. They must be in complete remission with no swelling and specific urine protein levels. They must have had at least one relapse in the 6 months before study start. Those who received cyclophosphamide must have relapsed after stopping it. Participants must have normal kidney function for their age.
Exclusions include those with other serious health conditions, current participation in other trials, recent infections, allergic reactions to similar medications, inability to follow procedures, pregnancy or breastfeeding, recent interfering treatments, substance abuse history, recent or planned surgery, and certain cancer history.
The study compares Obinutuzumab, given through intravenous infusion, with Mycophenolate Mofetil, available as oral powder or tablets. The study evaluates sustained complete remission at one year, number of relapses, overall relapse-free survival, and corticosteroid usage. Participants are monitored for side effects and health changes throughout the trial.
The investigational drugs are Obinutuzumab, a monoclonal antibody given intravenously that targets specific immune cells, and MMF (Mycophenolate Mofetil), an immunosuppressant taken orally that reduces immune system activity.
Summary
The 9 ongoing clinical trials for nephrotic syndrome represent a diverse research effort across Europe. A notable concentration of trials is occurring in France, which hosts 4 studies, while Poland hosts 4 trials as well. Several trials are multi-national, particularly the studies involving Atacicept and Obinutuzumab with Mycophenolate Mofetil, which span up to 6 countries.
The research shows a clear focus on immunosuppressive therapies, with Rituximab appearing in multiple trials for both children and adults. Obinutuzumab is being investigated in three separate studies, suggesting significant interest in this newer monoclonal antibody. Several trials specifically target pediatric populations, reflecting the condition’s prevalence in children and the need for age-appropriate treatment strategies.
Different forms of the condition are being addressed, including steroid-sensitive, steroid-dependent, frequently relapsing, and idiopathic membranous forms. This comprehensive approach suggests researchers are working to develop targeted therapies for specific patient subgroups rather than seeking a single treatment for all presentations of the syndrome.
The variety of investigational drugs ranges from established medications like Rituximab to newer compounds like AP1189 and nutritional approaches using ketoanalogues. Most trials focus on preventing relapses and reducing the need for corticosteroids, which are associated with significant side effects when used long-term. Study durations vary from 12 weeks to 24 months, with most following participants for at least one year to adequately assess relapse prevention.
