Status:
RECRUITING
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Lupus Nephritis
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
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 bu...
Detailed Description
Preliminary data show that the anti CD20 monoclonal antibody may effectively replace oral corticosteroids in the induction treatment of lupus glomerulonephritis. The concept of avoiding significant us...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04702256
Start Date
December 9 2021
End Date
December 1 2031
Last Update
November 24 2025
Active Locations (1)
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1
Internal medicine, Cochin hospital, APHP
Paris, France, 75014