Lupus Nephritis Clinical Trial
Official title:
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments.
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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