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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Jean Perrin Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Nimes Nimes France
Hopital Europeen Marseille Marseille France
Centre Hospitalier De Valenciennes Valenciennes France
Hopitaux Prives De Metz Vantoux France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Institut Sainte Catherine Avignon France
Centre Hospitalier Universitaire De Caen Normandie Caen France
CHU De Martinique Fort De France France
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Cpnzyi Hzlwxqwsnzx Ea Uizkityxejhxy Dw Lsyuwhd Limoges France
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Aeogyuerny Piuulzdb Hmkwgvop Do Mjvdvhzut Marseille France
Cilbst Hisczrepeez Reagemqi Ujekgpxvvrvmp Do Tfplv Tours France
Crdbzz Hiirtbctjqz Rlwndqfs Dsyrqnanofxopp Angers France
Hamrgmnt Uzzkuxtixczejt Sdxavovprg &bwlrsh Hryhpiy dw Hcxebrcimxn STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
09.12.2021

Trial locations

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.

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 ID:
2024-516242-19-00
Protocol code:
APHP200038
NCT ID:
NCT04702256
Trial Phase:
Therapeutic confirmatory (Phase III)

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