OBJECTIVE To test whether Rituximab (RTX) is efficacious to achieve complete renal response (CR) in Lupus Nephritis (LN) patients with persistent proteinuria (≥1g/d) despite at least 6 months of standard of care (SOC). STUDY DESIGN Investigator-initiated randomized international open multicentric 104-week study.
After screening (week -8), patients enter in a run-in period of 6 weeks during which treatment is unchanged. At week -2, if persistent proteinuria is confirmed (uP/C ratio ≥1 expressed in mg/mg), patients will be randomized in a 1/1 ratio to 1 of 2 treatment groups as follows : RTX group Subjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72.Control group Subjects will not receive RTX infusions. In both arms, azathioprine (AZA) or mycophenolate mofetil (MMF) will be continued. If prescribed, prednisolone dose should not be \> 10 mg/day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
RTX + Standard of Care
Standard of Care only
Cliniques Universitaires Saint Luc
Brussels, Belgium
RECRUITINGThe primary endpoint is the percentage of patients achieving renal complete response (CR) at w104.
CR is defined as : * uP/C ratio ≤0.5 (expressed in mg/mg) measured in a 24-h urine collection; and * eGFR \>=60ml/min or, if \<60ml/min at screening, not fallen by \>20% compared to screening; and * no increase of glucocorticoïds (GC) throughout the study (except for two limited courses as per protocol; vide infra); and * no introduction of another immunosuppressant.
Time frame: 104 weeks
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