Study on the Effectiveness and Safety of Obinutuzumab for Patients with Class III or IV Lupus Nephritis

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What is this study about?

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.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide consent to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes a review of your medical history and a physical examination. Blood and urine tests may be performed to assess your current health status.

3 treatment initiation

You will begin treatment with the study medication. The main medication being tested is obinutuzumab, which is administered through an intravenous infusion. You may also receive other medications such as methylprednisolone and prednisone to manage symptoms and support your treatment.

4 medication schedule

The obinutuzumab infusion will be given at specific intervals as determined by the study protocol. Methylprednisolone may be given as a pulse dose intravenously, and prednisone is taken orally. The exact dosage and frequency will be explained to you by the study team.

5 regular monitoring

Throughout the study, regular monitoring will be conducted to assess your response to the treatment. This includes blood tests, urine tests, and other assessments to monitor your kidney function and overall health.

6 follow-up visits

You will have scheduled follow-up visits with the study team. During these visits, your progress will be evaluated, and any side effects or concerns will be addressed.

7 completion of study

The study is expected to last until Week 76. At the end of the study, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Azienda Ospedaliera di Padova Padua Italy
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Clinic De Barcelona Barcelona Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Staedtisches Klinikum Dresden Dresden Germany
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Universita Degli Studi Di Brescia Brescia Italy
Rheuma Medicus Sp. z o.o. Warsaw Poland
Medyczne Centrum Hetmanska Poznan Poland
Hopital Beaujon Clichy France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
10.11.2020
Germany Germany
Not recruiting
10.11.2020
Italy Italy
Not recruiting
10.11.2020
Poland Poland
Not recruiting
10.11.2020
Spain Spain
Not recruiting
10.11.2020

Trial locations

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.

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 ID:
2023-503628-22-00
Protocol code:
CA41705
Trial Phase:
Therapeutic confirmatory (Phase III)

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