RING - Rituximab for Lupus Nephritis With Remission as a Goal
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||RING - Rituximab for Lupus Nephritis With Remission as a Goal, an Investigator-initiated Randomized International Open Multicentric Study|
- The primary endpoint is the percentage of patients achieving renal complete response (CR) at w104. [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: RTX group
Subjects will receive a RTX infusion (1g) at w0, w2, w24, w26, w48, w50, w72 and w74
Drug: RTX infusions
RTX + Standard of Care
Active Comparator: Control group
Subjects will not receive RTX infusions and will be followed in standard of care
Other: Standard of Care
Standard of Care only
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, w26, w48, w50,w72 and w74.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.
|Contact: Frédéric A Houssiau, MD PHD||+32 2 firstname.lastname@example.org|
|Contact: Geneviève J Depresseux, Trial Coord||+32 2 email@example.com|
|Cliniques Universitaires Saint Luc|
|Bruxelles, Belgium, 1200|
|Principal Investigator:||Frédéric A Houssiau, MD PHD||Cliniques universitaires Saint-Luc|