Actively Recruiting
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-24
196
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomised, open label, controlled non-inferiority phase III multicentre trial. As primary objective, the study aims to demonstrate that a regimen free of additional oral corticosteroids but with obinutuzumab (and MMF) is non-inferior to a regimen based on oral corticosteroids and MMF in achieving the primary outcome of complete renal response at week 52 without receiving corticosteroids above a prespecified dose. As secondary objectives, the study aims: * To compare the efficacy of the treatments in both arms in terms of: * partial plus complete renal response at week 52; * proteinuria \< 0.8g/g at week 52; * extrarenal flares; * response as defined by a \>4 points reduction in SELENA-SLEDAI score at week 52. * To compare the safety of the treatments in both arms in terms of occurrence of: * toxicity of corticosteroids; * serious Adverse Events; * serious Infectious Episodes; * new damage. * To compare the number of patients with non-adherence to treatment in both arms. * To estimate the efficiency of obinutuzumab in this indication. The ancillary studies will allow: * To implement a biobank (serum, plasma, DNA, cells and urine) and a bank of renal biopsies for studies that will be part of separate research funding bids (patients will be informed that their samples and data may be used for subsequent studies and offered to consent or not). * To identify which target therapeutic levels of MMF best predicts response with least toxicity (ancillary study). * To have long term data on renal function and damage.
CONDITIONS
Official Title
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 14 to 17 years old and adults
- Active lupus nephritis confirmed by kidney biopsy within the last 8 weeks, classified as ISN/RPS class III or IV (A or A/C) with or without class V, with at least 10% active lesions in viable glomeruli
- Urine protein-to-creatinine ratio (uPCR) of 0.5 g/g or higher within 14 days before inclusion
- No contraindications to intravenous methylprednisolone, MMF, oral corticosteroids, or obinutuzumab
- Ability to provide informed consent
- Willingness to use effective contraception while using MMF
You will not qualify if you...
- Severe lupus flare needing more immunosuppression than allowed by the protocol
- Inability to take prednisone corticosteroids at 10 mg daily or less as judged by the physician
- Pregnant or breastfeeding women
- Use of therapeutic monoclonal antibodies or biologic cell-modulating drugs (except belimumab) within 6 months before inclusion
- More than 60% damage or scarring of kidney glomeruli or tubulointerstitial tissue
- Chronic kidney disease stage 4 or 5 with estimated glomerular filtration rate below 30 ml/min/1.73 m2
- Active infections such as HIV, untreated hepatitis B, hepatitis C, or tuberculosis
- Receipt of live-attenuated vaccine within 4 weeks before enrollment
- History of severe cervical abnormalities or high-risk HPV in the past 3 years, unless followed by negative HPV test or treatment over one year ago
AI-Screening
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Trial Site Locations
Total: 1 location
1
Internal medicine, Cochin hospital, APHP
Paris, France, 75014
Actively Recruiting
Research Team
N
Nathalie COSTEDOAT-CHALUMEAU, MD, PhD
CONTACT
E
Eric DAUGAS, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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