Ongoing Clinical Trials for Henoch-Schönlein Purpura
Two clinical trials are currently investigating new treatment approaches for Henoch-Schönlein Purpura (also known as IgA Vasculitis, IgAV). These studies are exploring different medications aimed at reducing inflammation and protecting kidney function in both children and adults with this condition.
Clinical trial locations
- France
- Germany
- Italy
- Netherlands
- Poland
- Spain
- Sweden
Study on the Safety and Effects of Sparsentan for Children with Proteinuric Kidney Diseases
This trial is examining a medication called sparsentan in children with various kidney diseases that cause protein to leak into the urine, including IgA Vasculitis (the medical term for Henoch-Schönlein Purpura when it affects the kidneys). The study is taking place across multiple European countries, including Sweden, Germany, Italy, Netherlands, Poland, and Spain.
Who can join: Children aged 1 to 17 years old can participate if they have confirmed kidney disease with protein in their urine. For those with IgA Vasculitis specifically, participants must be at least 2 years old and have a urine protein level of 0.6 g/g or less, with kidney disease confirmed by biopsy or genetic testing. The child must have kidney function (eGFR) of at least 30 mL/min/1.73 m² and blood pressure within the normal range for their age and height. Parents or legal guardians must provide written consent, and the child must agree to participate.
Who cannot join: Children with other serious health conditions that might interfere with the study, those who are pregnant, those who recently had major surgery, or those currently in another clinical trial cannot participate. Children with uncontrolled high blood pressure, severe liver or kidney disease, an allergy to the study medication, or a history of certain heart conditions are also excluded. Those with a history of drug or alcohol abuse or who are unable to follow study procedures cannot take part.
What the trial involves: The study aims to evaluate how safe sparsentan is for children with these kidney conditions and whether it helps reduce protein levels in the urine. Sparsentan is given as a liquid medication taken by mouth once daily for 108 weeks (just over 2 years). Researchers will monitor kidney health through regular assessments, measuring changes in protein levels in the urine and tracking any side effects. The medication works by blocking specific receptors in the body to help reduce protein loss through the kidneys.
Investigational drug: Sparsentan is an oral suspension (liquid medication) that combines the actions of an angiotensin receptor blocker and endothelin receptor antagonist. It is being studied for its potential to reduce protein leakage from the kidneys in children with various proteinuric kidney diseases.
Study of rituximab and glucocorticoids versus placebo and glucocorticoids in adults with newly diagnosed or relapsing IgA vasculitis
This trial is investigating whether adding rituximab to standard steroid treatment is more effective than steroid treatment alone for adults with IgA Vasculitis. The study is being conducted in France and focuses on adults with newly diagnosed disease or those experiencing a relapse.
Who can join: Adults aged 18 and older with IgA Vasculitis confirmed by tissue biopsy can participate. Participants must have either newly diagnosed disease or a relapse with active symptoms and must have severe involvement of at least one organ. They must be within 21 days of starting or increasing steroid treatment at a dose of 1 mg per kg of body weight per day or less. Participants must have national health insurance coverage and be able to provide written informed consent.
Who cannot join: People under 18 years old or those without biopsy confirmation of the disease cannot participate. Those who have received rituximab in the past 6 months, have active or chronic infections (including hepatitis B or C, active tuberculosis, or HIV), are pregnant or breastfeeding, or have active cancer or a history of cancer in the past 5 years are excluded. People with severe heart, liver, or kidney disease, known allergic reactions to biological medications, or mental conditions that prevent understanding of the study requirements cannot join. Those participating in other clinical trials within the past 30 days are also excluded.
What the trial involves: The study compares two treatment approaches. All participants receive glucocorticoids (steroid medications), but they are randomly assigned to receive either rituximab or placebo (an inactive substance) through an intravenous infusion. The infusions are given during the first months of the study, and participants are monitored for 12 months. During this time, doctors track disease symptoms, kidney function, blood tests, and overall health. The main goal is to see how many patients achieve remission (improvement of symptoms) while being able to stop taking steroids completely at specific time points. Regular assessments include monitoring disease activity, documenting any relapses, recording side effects, and checking kidney function and blood pressure.
Investigational drugs: Rituximab is a biological medication that targets specific immune system cells called B-cells to reduce inflammation. It is given through intravenous infusion and works by binding to a protein on B-cells, leading to their destruction and thereby reducing inflammation. Glucocorticoids are anti-inflammatory steroid medications used as baseline treatment for all participants. They work by suppressing the immune system and reducing swelling throughout the body.
Summary
Currently, two clinical trials are available for people with Henoch-Schönlein Purpura, now more commonly known as IgA Vasculitis. These trials target different age groups and use different treatment approaches. The first trial focuses on children and is available across six European countries (Sweden, Germany, Italy, Netherlands, Poland, and Spain), testing a medication called sparsentan that aims to protect kidney function over a two-year period. The second trial is available only in France and focuses on adults with newly diagnosed or relapsing disease, investigating whether adding rituximab to standard steroid treatment improves outcomes.
Both studies reflect the ongoing effort to find better treatments for this condition, particularly for protecting kidney function, which is one of the most serious complications. The pediatric trial specifically addresses the need for treatments in children with kidney involvement, while the adult trial explores whether targeted immune system therapy can improve remission rates and allow patients to reduce or stop steroid medications, which often have significant side effects with long-term use.
