NCT01673295

RING - Rituximab for Lupus Nephritis With Remission as a Goal

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Frédéric A. Houssiau, MD, PhD · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	RTX infusions	RTX + Standard of Care
OTHER	Standard of Care	Standard of Care only

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-11-01
• Completion: 2016-11-01
• First posted: 2012-08-27
• Last updated: 2015-05-28

Locations

1 site across 1 country: Belgium