Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 7, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring new treatment options for lupus nephritis, a serious kidney condition associated with systemic lupus erythematosus (SLE). Specifically, the study is comparing two treatment approaches: one that uses a medication called obinutuzumab along with mycophenolate mofetil (MMF) without the addition of oral corticosteroids, and another that uses oral corticosteroids along with MMF. The main goal is to find out if the treatment without extra oral steroids is just as effective at improving kidney health after one year.

To participate in this trial, individuals must be between 14 and 17 years old or adults with active lupus nephritis, confirmed by a recent kidney biopsy showing certain types of kidney damage. They should also have a specific level of protein in their urine. Participants will receive regular check-ups and assessments throughout the study to monitor their kidney function and any side effects. It’s important to note that the trial will also collect samples for future research, and participants will have the option to agree to this. Overall, this trial aims to improve treatment options for patients with lupus nephritis while minimizing the use of corticosteroids, which can have harmful side effects.

Gender

ALL

Eligibility criteria

• 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.