Could a new drug replace steroids for lupus kidney patients?
NCT ID NCT04702256
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether a drug called obinutuzumab, combined with mycophenolate mofetil (MMF), can control lupus nephritis without the need for oral steroids. About 196 people with active lupus kidney disease will be randomly assigned to either the obinutuzumab/MMF regimen or standard steroid/MMF treatment. The main goal is to see if the steroid-free approach is just as good at achieving complete kidney response after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Obinutuzumab (a monoclonal antibody) and mycophenolate mofetil (MMF, an immunosuppressant)
- What this could lead to
- If successful, this could offer a steroid-free treatment option for lupus nephritis, reducing long-term side effects from steroids while still controlling the disease.
- What could go wrong
- This is a Phase 3 trial, but it's still experimental. The obinutuzumab regimen may not be as effective as steroids, and there are risks from the drug itself, including infusion reactions and increased infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 196 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Children aged 14-17 years old and adults; * Active lupus nephritis, as defined by kidney biopsy within the preceding 8 weeks, assessed by the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification: class III or IV (A or A/C) ± V with active lesions in at least 10% of the viable glomeruli; * Urine protein-to-creatinine ratio (uPCR) ≥ 0.5 g/g at any time in the 14 days before inclusion; * No contraindications to the use of IV methylprednisolone, MMF, oral corticosteroids or obinutuzumab; * Ability to provide informed consent; * Willingness to use appropriate contraception, as recommended when using MMF. Exclusion Criteria: * Severe "critical" SLE flare defined as any SLE manifestation requiring more immunosuppression than allowed in the protocol, in the physician's opinion; * Patients who cannot be prescribed 10 mg prednisone corticosteroids "only", after inclusion according to the physician's opinion; * Pregnant and breastfeeding woman; * Prior use within 6 months of inclusion of therapeutic monoclonal antibody and/or B- or T cell modulating 'biologic' except belimumab that can be used up to 7 days before inclusion; * Obsolescence of \>60% of the glomeruli or tubulointerstitial scarring of \>60%; * CKD stage 4 or stage 5 defined as eGFR \<30 ml/min/1.73 m2 according to CKD-EPI (to be differentiated from acute renal injury); * Active infections, including but not limited to human immunodeficiency virus (HIV), hepatitis B in the absence of a specific therapy, hepatitis C or tuberculosis; * Receipt of a live-attenuated vaccine in the 4 weeks prior to study enrolment; * History of cervical dysplasia CIN Grade III, cervical high-risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) in the past 3 years in female patients. However, the patient will be eligible in the following conditions: follow-up HPV test is negative or cervical abnormality was effectively treated \>1 year ago.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Internal medicine, Cochin hospital, APHP
RECRUITINGParis, 75014, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody aims to wipe out Lupus-Causing immune cells
- 5,000-Patient registry aims to map the Long-Term course of lupus nephritis
- Can a blood test catch lupus flares earlier?
- Can a single CAR-T infusion reset the immune system and stop lupus kidney damage?
- Can a single cell therapy calm multiple autoimmune diseases?
- Blood markers may foretell kidney trouble in lupus