Actively Recruiting

Phase 3
Age: 14Years +
All Genders
NCT04702256

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-24

196

Participants Needed

1

Research Sites

520 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

R

Roche Pharma AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 14 to 17 years old and adults
  • Active lupus nephritis confirmed by kidney biopsy within the last 8 weeks, classified as ISN/RPS class III or IV (A or A/C) with or without class V, with at least 10% active lesions in viable glomeruli
  • Urine protein-to-creatinine ratio (uPCR) of 0.5 g/g or higher within 14 days before inclusion
  • No contraindications to intravenous methylprednisolone, MMF, oral corticosteroids, or obinutuzumab
  • Ability to provide informed consent
  • Willingness to use effective contraception while using MMF
Not Eligible

You will not qualify if you...

  • Severe lupus flare needing more immunosuppression than allowed by the protocol
  • Inability to take prednisone corticosteroids at 10 mg daily or less as judged by the physician
  • Pregnant or breastfeeding women
  • Use of therapeutic monoclonal antibodies or biologic cell-modulating drugs (except belimumab) within 6 months before inclusion
  • More than 60% damage or scarring of kidney glomeruli or tubulointerstitial tissue
  • Chronic kidney disease stage 4 or 5 with estimated glomerular filtration rate below 30 ml/min/1.73 m2
  • Active infections such as HIV, untreated hepatitis B, hepatitis C, or tuberculosis
  • Receipt of live-attenuated vaccine within 4 weeks before enrollment
  • History of severe cervical abnormalities or high-risk HPV in the past 3 years, unless followed by negative HPV test or treatment over one year ago

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Internal medicine, Cochin hospital, APHP

Paris, France, 75014

Actively Recruiting

Loading map...

Research Team

N

Nathalie COSTEDOAT-CHALUMEAU, MD, PhD

CONTACT

E

Eric DAUGAS, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here