Ongoing Clinical Trials for Glomerulonephritis Acute
There is currently 1 ongoing clinical trial for glomerulonephritis acute, specifically focusing on membranous nephropathy, a form of kidney inflammation. This trial is testing a personalized approach to rituximab treatment using artificial intelligence to optimize dosing for individual patients.
Clinical trial locations
Study of personalized rituximab dosing using artificial intelligence in patients with membranous nephropathy
This clinical trial is examining a new way to give rituximab medication to people with membranous nephropathy, a kidney condition that causes protein to leak from the blood into the urine. The study compares a standard approach to giving rituximab with a personalized approach that uses artificial intelligence to determine the best dose for each patient.
Main inclusion criteria:
- Must be between 18 and 65 years old
- Must have confirmed membranous nephropathy, either through the presence of specific antibodies in blood or through kidney tissue examination
- Must have nephrotic syndrome with significant protein in urine (greater than 3.5 grams per 24 hours) and low blood albumin (less than 30 grams per liter)
- Must be eligible for rituximab treatment according to current medical guidelines
- Must have been on stable treatment for at least 2 weeks with blood pressure medications, diuretics, and a low-salt diet
- Must have adequate kidney function with a filtration rate above 30 milliliters per minute
Main exclusion criteria:
- Previous treatment with rituximab or similar medications
- Active infections such as hepatitis B, hepatitis C, HIV, or tuberculosis
- Severe heart conditions or uncontrolled high blood pressure
- Active cancer or history of cancer in the past 5 years
- Pregnancy or breastfeeding
- Recent participation in other clinical trials (within the past 30 days)
- Known allergies to rituximab or similar medications
- Severe kidney dysfunction beyond membranous nephropathy
Focus and goal of the trial:
The trial aims to test whether using artificial intelligence to personalize rituximab dosing can improve treatment outcomes compared to standard dosing. The computer algorithm predicts whether a patient might receive too little medication after three months of treatment and adjusts the dose accordingly. Patients will receive rituximab infusions over 45 days, with a maximum daily dose of 1 gram and a total maximum dose of 4 grams. The study will monitor kidney function, protein levels in blood and urine, and overall treatment response for up to 12 months after the first infusion.
Investigational drug:
The trial uses rituximab (brand name Truxima), a medication that targets specific cells in the immune system called B cells. Rituximab is a type of monoclonal antibody given through intravenous infusion. It works by binding to a protein called CD20 on the surface of B-cells, which leads to their destruction. This reduces the number of harmful antibodies the body produces, helping to decrease inflammation and damage to the kidneys. Rituximab is already used as a standard treatment for various autoimmune disorders, including membranous nephropathy.
The treatment follows a structured timeline with regular monitoring. Patients receive their first infusion on day 0, followed by blood sample collections on days 15, 30, and 45. Comprehensive evaluations occur at months 3, 6, 9, and 12, involving blood and urine tests to assess kidney function, medication levels, and treatment effectiveness.
Summary
Currently, there is only one clinical trial available for glomerulonephritis acute, specifically targeting membranous nephropathy. This trial is being conducted in France and represents an innovative approach to treatment by incorporating artificial intelligence to personalize rituximab dosing for individual patients. The focus on AI-driven personalization reflects a broader trend in medicine toward tailoring treatments based on individual patient characteristics rather than using a one-size-fits-all approach.
The trial is testing rituximab, a well-established medication in autoimmune disease treatment, but with a novel dosing strategy. This research may help determine whether personalized dosing can improve outcomes for patients with this kidney condition. The 12-month follow-up period allows researchers to thoroughly assess both the short-term and longer-term effects of this personalized treatment approach.