Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy

Sponsor
Fundación Pública Andaluza Progreso y Salud
Study ID
NCT01765842
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    Only one cycle of rituximab will be administered in this arm.

Study Details

Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments

Key Dates

Start date
Nov 30, 2012
Status verified
Jan 2013
Primary completion
Nov 30, 2014
Completion
Dec 31, 2015

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab (1 cycle)
    1 cycle of Rituximab (4 i.v. infusions): Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2
  • Experimental: Rituximab (2 cycles)
    A second cycle of Rituximab First cycle of Rituximab (4 i.v. infusions): Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2 Second cycle of Rituximab (4 i.v. infusions, 6 months later)

Primary Outcome Measure

Rate of complete or partial response in lupus nephritis [ Time Frame: Assessment at 12 months ]

Related Studies