Clinical Trials for Anti-neutrophil Cytoplasmic Antibody Positive Vasculitis
There are currently 7 ongoing clinical trials investigating new treatments for anti-neutrophil cytoplasmic antibody positive vasculitis. These trials are exploring various approaches including different dosing schedules of existing medications, new combinations of therapies, and innovative treatments like CAR-T cell therapy. The studies are taking place across several European countries including Austria, France, Germany, Netherlands, and Poland.
Clinical trial locations
- Austria
- France
- Study on Pioglitazone for Improving Kidney Health in Patients with ANCA-Associated Vasculitis
- Study on Continuing or Stopping Immunosuppressive Therapy with Rituximab in Patients with ANCA Vasculitis and End-stage Kidney Disease
- Study on Maintaining Remission in ANCA-Associated Vasculitis with Prednisone and Rituximab for Patients in Remission from Granulomatosis with Polyangiitis or Microscopic Polyangiitis
- Germany
- Netherlands
- Poland
Comparison of Once Versus Twice Daily Prednisolone Administration on Blood Glucose Control in Patients with ANCA-Associated Vasculitis
This study in Austria examines whether splitting the daily dose of prednisolone into two administrations leads to better blood sugar control compared to taking it once daily.
Main inclusion criteria: Participants must be adults aged 18-80 with either newly diagnosed or relapsing disease. They must be taking Aprednislon at a dose of 1mg per kilogram of body weight and be willing to wear a continuous glucose monitoring device throughout the study. Participants must also be willing to receive insulin therapy if needed.
Main exclusion criteria: The study excludes patients under 18 or over 65 years old, those with uncontrolled diabetes, active infections requiring immediate treatment, pregnant or breastfeeding women, and those with severe kidney or liver disease unrelated to their vasculitis. People with psychiatric conditions that could affect their ability to follow the study protocol are also excluded.
Study focus: The primary goal is to determine whether twice-daily dosing of corticosteroids provides better blood glucose control than once-daily dosing. Participants will be monitored continuously for blood sugar levels over a 14-day treatment period. The study will measure how long blood sugar levels remain within a healthy range and assess the impact on overall health and quality of life.
Investigational drugs: The study uses prednisolone (Aprednislon tablets), a corticosteroid medication that reduces inflammation and suppresses immune system responses. The research compares the same total daily amount given either once or split into two doses.
Study on Continuing or Stopping Immunosuppressive Therapy with Rituximab in Patients with ANCA Vasculitis and End-stage Kidney Disease
This French study investigates whether patients with end-stage kidney disease should continue or stop their immunosuppressive medications.
Main inclusion criteria: Participants must be aged 18-90 years with granulomatosis with polyangiitis or microscopic polyangiitis affecting the kidneys. They must have end-stage kidney disease, defined by a glomerular filtration rate of 15 or less, or require dialysis for more than 60 days. The kidney disease must be in the original kidneys, not transplanted ones. Participants must be part of the French social security system.
Main exclusion criteria: The trial excludes patients who do not meet the specific criteria for end-stage kidney disease or confirmed vasculitis diagnosis.
Study focus: The research aims to determine whether stopping immunosuppressive therapy is better than continuing standard maintenance treatment for patients with both conditions. Participants are randomly assigned to either continue or stop their medications and are monitored for 24 months for severe events such as major relapses, severe infections, or death.
Investigational drugs: The study involves rituximab (given by injection), azathioprine, prednisone, prednisolone, and mycophenolate mofetil (all taken orally). These medications work by reducing immune system activity to prevent it from attacking the body’s own tissues.
Study on Maintaining Remission in ANCA-Associated Vasculitis with Prednisone and Rituximab for Patients in Remission from Granulomatosis with Polyangiitis or Microscopic Polyangiitis
This French trial evaluates whether continuing low-dose prednisone helps maintain disease remission better than stopping it after a short period.
Main inclusion criteria: Participants must be 18 years or older with newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis. They must have achieved remission with treatments like rituximab, cyclophosphamide, or methotrexate and have been taking glucocorticoids for 12-36 months. At enrollment, they must be taking 5-10mg of prednisone daily, and at randomization, exactly 5mg daily. They must also have received a 500mg low-dose rituximab maintenance infusion.
Main exclusion criteria: The study excludes patients not currently in remission, those who haven’t achieved remission with the specified treatments, those unable to maintain a disease activity score of zero, and vulnerable populations requiring special protection.
Study focus: The study compares continuing low-dose prednisone versus stopping it to determine which approach better prevents disease flare-ups. Participants receive regular rituximab infusions and are monitored for up to 30 months for any return of symptoms.
Investigational drugs: The trial uses prednisone, a steroid that reduces inflammation, and rituximab, which targets specific immune system cells. Both medications work to prevent the immune system from attacking blood vessels.
Study on Pioglitazone for Improving Kidney Health in Patients with ANCA-Associated Vasculitis
This French study tests whether adding pioglitazone to standard treatment can reduce kidney damage in patients with vasculitis.
Main inclusion criteria: Participants must have newly diagnosed or relapsing disease with kidney involvement confirmed by a recent biopsy within the last 4 weeks. They must have protein and blood in their urine and an estimated glomerular filtration rate of at least 15 mL/min/1.73 m². Participants must be aged 18-80 years and affiliated with French health insurance.
Main exclusion criteria: The study excludes pregnant or breastfeeding women, those participating in other clinical trials, people with allergic reactions to the study medication, and those with other medical conditions that might interfere with the study or make participation unsafe.
Study focus: The research evaluates whether pioglitazone, typically used for diabetes management, can provide kidney protection when added to standard treatment with glucocorticoids and rituximab. Participants receive treatment for six months with regular monitoring of kidney function and overall health.
Investigational drugs: The trial uses pioglitazone (Actos 30mg tablets taken daily) alongside standard treatments of glucocorticoids and rituximab. Pioglitazone works by affecting glucose and fat metabolism and may have anti-inflammatory effects.
Study on Rituximab and Cyclophosphamide for Treating ANCA-Associated Vasculitis in Patients Seeking Remission
This Polish trial compares combination treatment with rituximab and cyclophosphamide versus cyclophosphamide alone, and later examines different methods of giving rituximab to maintain remission.
Main inclusion criteria: Participants must be 18 years or older with newly diagnosed or worsening disease showing high activity scores. They must have positive tests for specific antibodies (PR3-ANCA or MPO-ANCA) and must stop taking certain immune-suppressing medications by the screening day. Women who can become pregnant must use highly effective birth control during the study and for 12 months afterward, while men with female partners must use barrier contraception for 6 months after treatment.
Main exclusion criteria: The study excludes patients with conditions other than vasculitis, those unable to follow study procedures, pregnant or breastfeeding women, those in other clinical trials, people with recent infections, those with severe allergic reactions to study medications, and people with drug or alcohol abuse history.
Study focus: The study has two parts. The first evaluates whether combining rituximab with cyclophosphamide achieves remission better than cyclophosphamide alone within 26 weeks. The second part compares two ways of giving rituximab (under the skin versus into a vein) for maintaining remission up to 104 weeks. The study also examines genetic factors influencing disease development and treatment response.
Investigational drugs: Rituximab targets specific immune system cells to reduce inflammation. Cyclophosphamide is a chemotherapy drug that suppresses the immune system. Both are tested for their effectiveness in achieving and maintaining disease remission.
Study on the Effects of Rituximab and Cyclophosphamide in Patients with ANCA Vasculitis
This Dutch study compares using rituximab alone versus combining it with cyclophosphamide for maintaining disease remission.
Main inclusion criteria: Participants must have a clinical diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis. They must be at least 18 years old with newly diagnosed or relapsed disease affecting at least one major organ such as the kidney, lung, heart, or nervous system. The disease must require treatment with cyclophosphamide or rituximab. Participants must have positive tests for anti-PR3 or anti-MPO antibodies and be willing to provide informed consent and follow study requirements.
Main exclusion criteria: The study excludes patients without confirmed vasculitis diagnosis, those outside the specified age range, and vulnerable populations requiring special protection.
Study focus: The research evaluates the number of rituximab infusions needed to maintain remission over two years. It monitors the time needed for disease-related antibodies to become undetectable, the duration of immune cell depletion, and any side effects. The study also assesses quality of life and disease activity throughout participation.
Investigational drugs: Rituximab is given as an intravenous infusion to target immune cells causing inflammation. Cyclophosphamide may be used in combination to suppress the immune system and reduce inflammation.
Study of KYV-101, Fludarabine Phosphate, and Cyclophosphamide Monohydrate for Patients with Treatment-Resistant ANCA Vasculitis
This German study explores an innovative therapy using specially modified immune cells (CAR-T cells) for patients whose disease hasn’t responded to standard treatments.
Main inclusion criteria: Participants must be aged 18-75 years with active disease showing a specific activity score of 3 or higher. They must have had insufficient response or intolerance to glucocorticoids and at least one other treatment (rituximab, mycophenolate mofetil, azathioprine, methotrexate, cyclophosphamide, or avacopan). Those with granulomatosis with polyangiitis must have detectable anti-PR3 antibodies, while those with microscopic polyangiitis must have anti-MPO antibodies. Participants must have no active infection, normal results on brain, heart, and lung tests, and kidney function above a certain level. Women must have negative pregnancy tests and use effective contraception for 12 months after treatment.
Main exclusion criteria: The study excludes patients without active, treatment-resistant disease, those outside the age range, and vulnerable populations.
Study focus: This research assesses the safety and effectiveness of Anti-CD19 CAR-T cell therapy in treatment-resistant cases. The therapy uses the patient’s own immune cells, modified in a laboratory to attack disease-causing cells. Participants undergo preparation with fludarabine and cyclophosphamide before receiving the modified cells. The study includes long-term follow-up for up to 15 years to ensure treatment safety and effectiveness.
Investigational drugs: The main treatment is Anti-CD19 CAR-T cell therapy, where a patient’s T cells are modified to recognize and destroy cells with the CD19 protein. Fludarabine phosphate and cyclophosphamide monohydrate are used to prepare the body before the CAR-T cell infusion.
Summary
The seven ongoing clinical trials for anti-neutrophil cytoplasmic antibody positive vasculitis show a diverse approach to improving treatment. France is conducting the most trials with three studies, focusing on treatment optimization in patients with kidney involvement and maintenance of remission. The research spans various treatment approaches, from optimizing existing therapies like corticosteroids and rituximab to exploring innovative treatments such as CAR-T cell therapy.
Several trials focus on rituximab, either examining optimal dosing schedules, comparing it with other treatments, or evaluating whether continuing therapy benefits patients with severe kidney disease. This reflects rituximab’s central role in managing the condition. The German trial represents a significant advancement by investigating CAR-T cell therapy for treatment-resistant cases, potentially offering hope for patients who haven’t responded to conventional treatments.
The studies also address important practical questions, such as whether splitting corticosteroid doses improves blood sugar control and whether adding medications like pioglitazone can provide additional kidney protection. These trials collectively aim to refine treatment strategies, reduce side effects, and improve long-term outcomes for patients living with this challenging autoimmune condition.
