Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study of Obinutuzumab and Mycophenolate Mofetil Without Oral Corticosteroids for Treatment of Lupus Nephritis

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating lupus nephritis, a kidney inflammation that occurs in people with lupus. The study compares two different treatment approaches. The first approach uses mycophenolate mofetil (MMF) together with oral corticosteroids, while the second approach combines MMF with obinutuzumab (Gazyvaro) without additional oral corticosteroids.

The purpose of this research is to determine if treating patients with obinutuzumab and MMF without additional oral corticosteroids works as well as the traditional treatment using corticosteroids and MMF. The study measures how well the kidneys respond to treatment after 52 weeks. During the treatment period, patients receive their assigned medications according to a specific schedule. Obinutuzumab is given through an intravenous infusion, while MMF is taken as oral tablets.

Throughout the study, doctors monitor kidney function by checking protein levels in urine and measuring how well the kidneys filter blood. They also track any side effects that may occur during treatment. Some patients may also receive other medications like azathioprine or prednisolone as part of their treatment plan.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: mycophenolate mofetil (MMF) with oral corticosteroids

    Group 2: mycophenolate mofetil (MMF) with obinutuzumab (given through vein infusion)

  2. Step 2

    Treatment period - First 6 months

    If assigned to Group 1: You will receive oral mycophenolate mofetil and oral corticosteroids daily

    If assigned to Group 2: You will receive oral mycophenolate mofetil daily and obinutuzumab through vein infusion. Corticosteroid dose will not exceed 10 mg per day

  3. Step 3

    Treatment period - Months 6 to 12

    Treatment continues with adjusted medication doses

    If in Group 2: Corticosteroid dose will not exceed 7.5 mg per day during this period

  4. Step 4

    Medical evaluations

    Regular testing of kidney function through:

    Urine protein-to-creatinine ratio measurements

    Kidney function tests (estimated glomerular filtration rate)

    Regular health assessments to monitor treatment response

  5. Step 5

    Final evaluation - Week 52

    Assessment of kidney function through final tests

    Evaluation of treatment response based on protein levels in urine and kidney function

    Review of any side effects or complications during the treatment period

Who can join the trial?

6 criteria

  • Patient must be between 14 and 75 years old
  • Patient must have active lupus nephritis confirmed by kidney biopsy within the last 8 weeks, showing specific type of kidney damage (class III or IV with or without class V) affecting at least 10% of kidney filtering units
  • Patient must have elevated levels of protein in urine, measured by urine protein-to-creatinine ratio of 0.5 g/g or higher within 21 days before joining the study
  • Patient must be able to understand and sign an informed consent form
  • Women who can become pregnant must agree to use effective birth control methods for 18 months after starting the study
  • Patient must be registered in the French social security system (as a beneficiary or legal recipient)

Who cannot join the trial?

15 criteria

  • Age below 18 years old or above 75 years old
  • Previous severe allergic reactions to biological medications (medications derived from living organisms)
  • Active or chronic infections, including hepatitis B, hepatitis C, HIV, or tuberculosis
  • Severe kidney disease requiring dialysis (a procedure to filter blood when kidneys don't work properly)
  • History of cancer within the past 5 years
  • Pregnancy or breastfeeding
  • Severe heart conditions or uncontrolled high blood pressure
  • Current participation in other clinical trials
  • Major surgery planned during the study period
  • Severe mental health conditions that could interfere with study participation
  • Use of live vaccines within 4 weeks before starting the study
  • History of drug or alcohol abuse within the past year
  • Severe liver disease or abnormal liver function tests
  • Use of prohibited medications that could interfere with study treatments
  • Inability to follow study procedures or attend scheduled visits
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Obinutuzumab

    is a medication used to treat certain autoimmune conditions. It works by targeting specific immune cells called B-cells that can contribute to inflammation and damage in lupus nephritis. It is given as an intravenous infusion in a medical setting.

  • Mycophenolate mofetil (MMF)

    is an immunosuppressant medication that helps control the immune system's response. It is commonly used to treat lupus nephritis and prevent organ rejection in transplant patients. It works by reducing the activity of certain immune cells that can cause inflammation and damage to the kidneys.

  • Corticosteroids

    are medications that reduce inflammation and suppress the immune system. They are commonly used to treat various autoimmune conditions, including lupus nephritis. These medications help control inflammation and reduce symptoms of the disease.

What is already known about the treatment

  • Obinutuzumab

    An intravenously administered monoclonal antibody medication used in the treatment of lupus nephritis, a serious kidney complication of systemic lupus erythematosus. This targeted biological therapy works by depleting specific B-cells (CD20-positive B lymphocytes) in the immune system, helping to reduce inflammation and kidney damage. The medication belongs to the class of monoclonal antibodies and is being studied as a potential steroid-sparing alternative in combination with mycophenolate mofetil for lupus nephritis treatment.

  • Mycophenolate mofetil (MMF)

    An oral immunosuppressant medication that works by blocking the production of DNA in certain immune cells, thereby reducing their ability to attack healthy tissues in conditions like lupus nephritis. It is commonly used in combination with other medications to treat autoimmune conditions and prevent organ rejection in transplant patients. The medication belongs to the class of immunosuppressive agents and has shown effectiveness in managing kidney inflammation when used as part of combination therapy.

Investigated diseases

Lupus Nephritis - A kidney disease that occurs as a complication of systemic lupus erythematosus (SLE), where the body's immune system attacks the kidneys. The condition causes inflammation in the small blood vessels and other structures in the kidneys that filter waste from the blood. This inflammation leads to protein leakage into the urine and can cause swelling in various body parts. Over time, the kidney's filtering function may become impaired, affecting their ability to remove waste products from the blood. The disease can vary in severity, with symptoms ranging from mild to more pronounced kidney problems.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516242-19-00Protocol codeAPHP200038Estimated enrolment196 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.