Azienda Ospedaliera di Padova
Verified
Padua, Italy
Not recruiting
Study on the Effectiveness and Safety of Obinutuzumab for Patients with Class III or IV Lupus Nephritis
Verified siteRegistered drug
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effectiveness and safety of a medication called obinutuzumab in patients with a kidney condition known as lupus nephritis. Lupus nephritis is a complication of lupus, an autoimmune disease where the body's immune system mistakenly attacks its own tissues, leading to inflammation in the kidneys. The study aims to determine how well obinutuzumab works in treating this condition compared to a placebo. Obinutuzumab is administered through an intravenous infusion, which means it is given directly into a vein.
Participants in the study will receive either obinutuzumab or a placebo, and their progress will be monitored over a period of 76 weeks. The study will assess the proportion of patients who achieve a complete renal response, which means their kidney function improves significantly. Other medications involved in the study include methylprednisolone acetate, a type of steroid used to reduce inflammation, and mycophenolate mofetil, an immunosuppressant that helps control the immune system. These medications are part of the standard treatment for lupus nephritis and will be used alongside obinutuzumab or placebo.
The study will also evaluate the safety of obinutuzumab by monitoring any side effects experienced by participants. This includes checking for infusion-related reactions, changes in blood cell counts, and any signs of infection. The goal is to ensure that the treatment is not only effective but also safe for patients with lupus nephritis. Participants will have regular check-ups and tests to track their health and the effects of the treatment throughout the study period.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Must have a kidney condition called Lupus Nephritis (LN), specifically active or active/chronic Class III or IV, confirmed by a kidney biopsy within the last 6 months.
- Must have a diagnosis of Systemic Lupus Erythematosus (SLE), which is a condition that affects the immune system. This diagnosis should meet specific criteria, including having Class III or IV LN and a positive test for antinuclear antibodies (ANA) at least once.
- Must have a urinary protein-to-creatinine ratio (UPCR) of 1 gram per gram or higher, measured in a 24-hour urine collection at the time of screening. This test checks for protein in the urine, which can indicate kidney problems.
- Must have received at least one dose of a medication called methylprednisolone (at least 250 mg) or an equivalent medication for the current episode of active LN within the last 6 months or during screening. Alternatively, this medication can be given on the first day before the first treatment. A maximum of 3 grams of methylprednisolone or equivalent is allowed in the 4 weeks before screening or during screening.
- Must be between the ages of 18 and 65.
- Both male and female participants are eligible.
Who cannot join the trial?
10 criteria
- Patients who have a history of severe allergic reactions to the study medication.
- Patients with active infections that require treatment.
- Patients who are pregnant or breastfeeding.
- Patients with a history of cancer within the last 5 years, except for certain skin cancers.
- Patients with severe heart disease.
- Patients with uncontrolled high blood pressure.
- Patients with severe liver disease.
- Patients who have received another investigational drug within the last 30 days.
- Patients with a history of drug or alcohol abuse within the last year.
- Patients with any other medical condition that the study doctors think would make it unsafe to participate.
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Azienda Ospedaliero Universitaria Careggi
ResponsiveFlorence, ItalyAzienda Ospedaliero Universitaria Consorziale Policlinico di Bari
VerifiedBari, Italy
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Investigated drugs
Obinutuzumab is a medication used in this clinical trial to treat patients with a specific type of kidney inflammation called lupus nephritis. It works by targeting and attaching to certain cells in the immune system, which can help reduce inflammation and prevent further damage to the kidneys. The goal of using obinutuzumab in this study is to see if it can help patients achieve a complete recovery of kidney function over time.
What is already known about the treatment
Obinutuzumab – Obinutuzumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied in clinical trials for its effectiveness and safety in treating lupus nephritis, a kidney condition associated with lupus. The main therapeutic use of obinutuzumab in this context is to help patients achieve a complete renal response, which means improving kidney function and reducing inflammation. At the molecular level, obinutuzumab works by targeting a specific protein on the surface of certain immune cells, leading to their destruction and reducing the immune system's attack on the kidneys. It is classified as a monoclonal antibody, a type of medication designed to target specific cells in the body.
Investigated diseases
Lupus Nephritis – Lupus Nephritis is an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease. It occurs when the immune system attacks the kidneys, leading to inflammation and potential damage. The disease can cause the kidneys to become less effective at filtering waste and excess fluids from the blood. Over time, this can lead to proteinuria, where protein leaks into the urine, and hematuria, where blood is present in the urine. The progression of Lupus Nephritis can vary, with some individuals experiencing mild symptoms and others developing more severe kidney damage. The condition can lead to changes in kidney function, which may be monitored through various laboratory tests.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503628-22-00Protocol codeCA41705Estimated enrolment271 patientsSponsorF. Hoffmann-La Roche AG
sourced from the EU Clinical Trials Register and site verification
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