NCT04702256 Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF
| NCT ID | NCT04702256 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Lupus Nephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2021-12-09 |
| Primary Completion | 2031-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 196 participants in total. It began in 2021-12-09 with a primary completion date of 2031-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Nathalie COSTEDOAT-CHALUMEAU, MD, PhD
PRINCIPAL INVESTIGATOR
Centre de référence maladies auto-immunes et systémiques rares, Internal medicine, Cochin hospital, APHP
Frequently Asked Questions
Who can join the NCT04702256 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04702256 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 196 participants.
Is NCT04702256 currently recruiting?
Yes, NCT04702256 is actively recruiting participants. Contact the research team at nathalie.costedoat@gmail.com for enrollment information.
Where is the NCT04702256 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04702256 clinical trial?
NCT04702256 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Nathalie COSTEDOAT-CHALUMEAU, MD, PhD at Centre de référence maladies auto-immunes et systémiques rares, Internal medicine, Cochin hospital, APHP. The trial plans to enroll 196 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.