RING - Rituximab for Lupus Nephritis With Remission as a Goal (RING)
|ClinicalTrials.gov Identifier: NCT01673295|
Recruitment Status : Unknown
Verified May 2015 by Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain.
Recruitment status was: Recruiting
First Posted : August 27, 2012
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Drug: RTX infusions Other: Standard of Care||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RING - Rituximab for Lupus Nephritis With Remission as a Goal, an Investigator-initiated Randomized International Open Multicentric Study|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2016|
Experimental: RTX group
Subjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72.
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
- The primary endpoint is the percentage of patients achieving renal complete response (CR) at w104. [ Time Frame: 104 weeks ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673295
|Contact: Frédéric A Houssiau, MD PHD||+32 2 email@example.com|
|Contact: Geneviève J Depresseux, Trial Coord||+32 2 firstname.lastname@example.org|
|Cliniques Universitaires Saint Luc||Recruiting|
|Bruxelles, Belgium, 1200|
|Contact: Frédéric A Houssiau, MD PHD +32 2 7645391 email@example.com|
|Contact: Geneviève J Depresseux, Trial Coord +32 2 7645395 firstname.lastname@example.org|
|Principal Investigator: Frédéric A Houssiau, MD PHD|
|Principal Investigator:||Frédéric A Houssiau, MD PHD||Cliniques universitaires Saint-Luc|