Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

Who is this study for? Patients with lupus nephritis
What treatments are being studied? Obinutuzumab+Methylprednisolone+Paracetamol+Dexchlorpheniramine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Internal medicine, Cochin hospital, APHP
RECRUITING
Paris
Contact Information
Primary
Nathalie COSTEDOAT-CHALUMEAU, MD, PhD
nathalie.costedoat@gmail.com
+33 (0)6 87 50 81 23
Backup
Eric DAUGAS, MD, PhD
eric.daugas@aphp.fr
+33 (0) 1 40 25 71 01
Time Frame
Start Date: 2021-12-09
Estimated Completion Date: 2031-12
Participants
Target number of participants: 196
Treatments
Experimental: Obinutuzumab arm
Obinutuzumab administration plus oral mycophenolate mofetil (MMF)
Active_comparator: Corticosteroids arm
Oral corticosteroids plus MMF
Sponsors
Collaborators: Roche Pharma AG
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov