NCT01765842

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Randomized, open, controlled, multicenter, clinical trial in patients with lupus nephritis previously treated with cyclophosphamide and mycophenolate. These patient can not have received Rituximab in the previous year. The number of patients estimated to reach statistical significance is 18 in each arm, a total sample size of 32 patients is needed. The hypothesis is that the alternative procedure (a second cycle of Rituximab)will reduce the relapse rate of lupus nephritis and the consequent deterioration of renal function. Besides it will reduce health care expenses(hospitalization, medication, hemodialysis and renal transplantation).

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	Rituximab	Only one cycle of rituximab will be administered in this arm.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-11-01
• Completion: 2015-12-01
• First posted: 2013-01-10
• Last updated: 2015-07-10

Locations

3 sites across 1 country: Spain