Ongoing Clinical Trials for Glomerulonephritis
There are currently 4 clinical trials investigating new treatments for glomerulonephritis, a condition where the tiny filters in the kidneys become inflamed and damaged. These studies are taking place across several European countries including France, Lithuania, the Netherlands, and Poland, and are testing various approaches to managing this kidney disease and related conditions.
Clinical trial locations
- France
- Lithuania
- Netherlands
- Poland
Study of Desmopressin for Prevention of Bleeding After Kidney Biopsy in Patients with Rare Glomerulonephritis
This study, conducted in Poland, focuses on preventing bleeding complications during kidney biopsy procedures in patients with rare forms of the condition. A kidney biopsy is an important diagnostic procedure, but it carries some risk of bleeding.
Main focus: The trial evaluates whether desmopressin, a medication that helps blood clot more effectively, can reduce bleeding complications after kidney biopsy. Participants receive either desmopressin (brand name Minirin) or a placebo as a single intravenous injection before their biopsy procedure. The study monitors patients for 24 and 48 hours after the procedure to check for bleeding events and changes in blood sodium levels.
Who can participate: Adults aged 18 to 65 years who need a kidney biopsy as determined by their kidney specialist. Participants must have blood hemoglobin levels above 8g/dl, platelet counts above 100,000 per microliter, normal blood clotting test results, and controlled blood pressure below 160 mmHg. The biopsy site must be free from infection or inflammation.
Who cannot participate: People with known bleeding disorders, those taking blood-thinning medications other than aspirin or heparin, individuals with uncontrolled high blood pressure, those with a history of severe allergic reactions to desmopressin, pregnant or breastfeeding women, people with active infections, those with severe kidney dysfunction requiring dialysis, and individuals with heart failure or significant heart problems.
Investigational drug: Desmopressin is a synthetic hormone that helps control bleeding by temporarily increasing blood clotting factors in the bloodstream. It works by stimulating the release of von Willebrand factor and Factor VIII from blood vessel walls, which are important for blood clotting.
Study on the Effects of Belimumab and Rituximab for Patients with Severe Systemic Lupus Erythematosus
This study in the Netherlands examines treatment for Systemic Lupus Erythematosus, an autoimmune disease that can cause inflammation affecting the kidneys and other organs. Kidney involvement in lupus can lead to a form of the condition.
Main focus: The trial tests whether combining two medications, belimumab (given as a subcutaneous injection under the skin) and rituximab (given as an intravenous infusion), is more effective than standard treatments like mycophenolate and steroids. The study lasts about two years and monitors how well the combination reduces disease activity and affects the immune system over time.
Who can participate: Adults aged 18 years or older with a clinical diagnosis of severe, active Systemic Lupus Erythematosus. Participants must have a disease activity score of 12 or more on the SLEDAI index or worsening symptoms affecting major organs. They should have ongoing or worsening disease despite using standard immune-suppressing treatments, and must test positive for specific antibodies related to lupus. Female participants must not be pregnant or nursing and must use effective birth control.
Who cannot participate: Pregnant or breastfeeding women, people with a history of severe allergic reactions to the study medications, those with active infections requiring treatment, individuals with other autoimmune diseases that might interfere with the study, those who have received certain lupus treatments recently, people with significant heart, liver, or kidney problems, recent participants in other clinical trials, those with a history of cancer (except certain skin cancers), and individuals with a history of drug or alcohol abuse.
Investigational drugs: Belimumab targets and reduces the activity of B-cells, a type of immune cell, by inhibiting a protein called B-lymphocyte stimulator. Rituximab works by depleting B-cells through targeting the CD20 protein on their surface. Both are monoclonal antibodies used to control the autoimmune activity in lupus.
Study on the Safety and Effects of OMS906 for Patients with C3 Glomerulopathy and Idiopathic Immune Complex-Mediated Glomerulonephritis
This trial, conducted in Lithuania and Poland, studies two specific types of kidney diseases: C3 Glomerulopathy and Idiopathic Immune Complex-Mediated Glomerulonephritis. Both conditions affect the kidneys’ ability to filter waste from the blood.
Main focus: The study tests the safety and effects of OMS906, an investigational drug given as an intravenous infusion at a dose of 5 mg/kg every 4 weeks. Researchers monitor how well participants tolerate the drug and observe changes in kidney function and protein levels in urine, which are important indicators of kidney health.
Who can participate: Adults aged 18 years or older with a biopsy-confirmed diagnosis of C3 Glomerulopathy or Idiopathic Immune Complex-Mediated Glomerulonephritis within the past 36 months. Participants must have current vaccinations for certain bacteria, two 24-hour urine protein-to-creatinine ratio tests showing 0.8 gm/gm or higher, an estimated glomerular filtration rate of 45 mL/min/1.73m² or higher, and serum C3 concentration lower than normal. They must be on stable doses of blood pressure medications for at least 90 days. Female participants of childbearing potential must have negative pregnancy tests and use highly effective birth control.
Who cannot participate: People with other serious health conditions that could affect safety, those currently in another clinical trial, individuals with recent infections, pregnant or breastfeeding women, those with a history of allergic reactions to similar medications, people with a history of drug or alcohol abuse, and those unable to follow study procedures.
Investigational drug: OMS906 is an immunomodulatory agent administered intravenously that targets specific pathways involved in the immune response contributing to kidney damage. It is being studied in a Phase 2 trial to evaluate its safety and preliminary effectiveness.
Study of Peginterferon Alfa-2a for Patients with Extramembranous Glomerulonephritis
This French study focuses on extramembranous glomerulonephritis, a condition involving inflammation of the tiny filters in the kidneys, which can lead to kidney damage and protein leaking into the urine.
Main focus: The trial observes the immune system’s activity in patients who have experienced a return of symptoms. It uses a personalized approach focusing on a specific part of the immune system known as the Th17 pathway. Participants receive Pegasys (peginterferon alfa-2a) as a subcutaneous injection of 180 micrograms once monthly for six months. Researchers monitor changes in certain antibodies and proteins in the blood to assess how the treatment affects immune system markers.
Who can participate: Adults aged 18 years or older with extramembranous glomerulonephritis and specific anti-PLA2R1 autoantibodies in their blood. Participants must have experienced an immunological relapse, defined as an increase in anti-PLA2R1 antibody levels greater than 14 RU/mL after a period when these antibodies were absent. They must have IL-17A plasma levels greater than 73 pg/mL and be receiving stable, maximum tolerated symptomatic treatment. Blood tests must show adequate platelet counts (at least 90,000 cells/mm3), neutrophil counts (at least 1,500 cells/mm3), and normal thyroid function.
Who cannot participate: Patients who do not have the required Th17-like cytokine profile, those not experiencing an immunological relapse, individuals outside the age range of 18 to 65 years, and those considered part of vulnerable populations such as children or those unable to make decisions for themselves.
Investigational drug: Pegasys (peginterferon alfa-2a) is an immunomodulatory medication that works by interacting with specific proteins in the body to modulate immune activity. It helps regulate the immune response, particularly involving Th17 cells, to reduce inflammation and immune system overactivity.
Summary
These four clinical trials represent diverse approaches to treating the condition and related kidney diseases. The studies are concentrated in European countries, with Poland hosting two trials and France, Lithuania, and the Netherlands each hosting one study.
The trials address different aspects of kidney disease management, from preventing complications during diagnostic procedures to treating the underlying inflammatory and immune processes. Two studies focus on specific rare forms of the condition, while others address related autoimmune conditions that can affect the kidneys.
The investigational treatments being tested include desmopressin for bleeding prevention, combination therapy with belimumab and rituximab for lupus-related kidney disease, OMS906 for C3 Glomerulopathy and immune complex-mediated disease, and peginterferon alfa-2a for extramembranous forms. These diverse approaches reflect the complexity of kidney diseases and the need for targeted therapies for different patient populations.
Most trials require participants to have stable doses of existing medications and meet specific diagnostic criteria, emphasizing the importance of careful patient selection in studying these conditions. Vaccination requirements and pregnancy prevention measures are common across several studies, highlighting safety considerations in immunomodulatory research.
