Treatment of lupus nephropathy without the addition of oral corticosteroids: a study comparing conventional corticosteroid and Mycophenolate Mofetil (MMF) therapy with Obinutuzumab and MMF
- Conditions
- The study population will consist of Children (14 years and above) and adults (until 75 years old) with lupus nephritis ISN/RPS class III or IV (A or A/C) ± V with active lesions in at least 10% of the viable glomeruli, AND urine protein-to-creatinine ratio (uPCR) = 0.5 g/g.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2020-005835-60-FR
- Lead Sponsor
- Assistance Publique – Hôpitaux de Paris (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 196
-Children aged 14-17 years old and adults (until 75 years old)
-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
-Ability to provide informed and signed consent
-For child-bearing aged women, willingness to use appropriate and efficient contraception, as recommended when using MMF and obinutuzumab (18 months after inclusion)
-Affiliation to a French social security system (beneficiary or legal)
Are the trial subjects under 18? yes
Number of subjects for this age range: 14
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 176
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
-Severe critical SLE flare defined as any SLE manifestation requiring more immunosuppression than allowed within the protocol, in the physician's opinion
-Patients who cannot be prescribed 10 mg prednisone corticosteroids only, after inclusion according to their physician
-Prior use within 6 months preceding 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
-Contraindications to the use of IV methylprednisolone, MMF, oral corticosteroids or obinutuzumab, or its premedication drugs listed in the corresponding SmPCs
-Hypersensitivity to the active substances or to any of the excipients
-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)
-Patients with gastro-intestinal ulcer with active bleeding
-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 before study enrolment
-Patient who has presented a malignant pathology in the previous 2 years (with the exception of cervical cancer in situ)
-In female patients, known 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) within the past 3 years. However, the patient will be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality was effectively treated >1 year ago).
-Patients with hepatic or pulmonary insufficiency
-Progressive cardiac pathology
-Patients with uncontrolled hypertension or hypotension
-Participation in another interventional study or being in the exclusion period at the end of a previous study.
-Pregnancy and breast feeding
-Patient under tutorship or guardianship, and incapable to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method