Comparing treatments for lupus nephritis without added oral steroids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial aims to compare the effectiveness of a treatment regimen for lupus nephritis that uses obinutuzumab and mycophenolate mofetil (MMF) without additional oral corticosteroids against a regimen that includes oral corticosteroids and MMF. The primary goal is to demonstrate that the steroid-free regimen is non-inferior in achieving complete renal response at 52 weeks. Secondary objectives include assessing partial renal responses, proteinuria levels, extrarenal flares, and safety outcomes related to corticosteroid use. The study will involve randomization of eligible patients across multiple centers, with assessments conducted at regular intervals over the course of the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Internal medicine, Cochin hospital, APHP
  Paris, France Recruiting

Study contacts

• Principal investigator: Nathalie COSTEDOAT-CHALUMEAU, MD, PhD — Centre de référence maladies auto-immunes et systémiques rares, Internal medicine, Cochin hospital, APHP
• Study coordinator: Nathalie COSTEDOAT-CHALUMEAU, MD, PhD
• Email: nathalie.costedoat@gmail.com
• Phone: +33 (0)6 87 50 81 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.