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

Lupus Nephritis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01765842
Study type Interventional
Source Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Contact
Status Terminated
Phase Phase 3
Start date November 2012
Completion date December 2015
View Details
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