A Prospective, Multicenter Trial to Explore the Efficacy and Safety of Obinutuzumab Adds on to Standard-of-care Therapy Consisting of Mycophenolate Mofetil (MMF) and Corticosteroids (O-triple) as Initial Therapy in the Active Lupus Nephritis Patients

ConditionLupus Nephritis

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-65

SponsorZhao Minghui

About this trial

This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patients

Eligibility criteria

Qualifiers

Signed Informed Consent Form

Age 18 to 65 years at time of signing Informed Consent Form

Ability to comply with the study protocol, in the investigator's judgment

ISN/RPS 2003 Class III, IV, V active/active chronic LN by renal biopsy performed within the 1 month prior to screening or during screening with 24hUPCR≥1g/g

Disqualifiers

Are pregnant or breastfeeding.

Have severe renal impairment, defined as eGFR < 30 mL/min/1.73 m² (estimated using the CKD-EPI equation), or require dialysis or renal transplantation.

Have renal biopsy showing > 50% glomerular sclerosis.

Have pure chronic renal biopsy findings: no active lesions.

Trial design

Treatments tested in this trial

obinutuzumab (RO5072759)

Treatment groups

70 Participants

are divided into 1 treatment group

Locations14

Select a site below to view it on the map.

Sponsors and collaborators

Zhao Minghui

Lead sponsor

Peking University First Hospital

Sponsor institution

Source ClinicalTrials.gov