Clinical Trial: RING - Rituximab for Lupus Nephritis With Remission as a Goal

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: RING - Rituximab for Lupus Nephritis With Remission as a Goal, an Investigator-initiated Randomized International Open Multicentric Study

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Frédéric A. Houssiau, MD, PhD

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Université Catholique de Louvain

Dates:
Date Received: August 22, 2012
Date Started: November 2014
Date Completion: November 2016
Last Updated: May 27, 2015
Last Verified: May 2015