Patrocinado por: Hoffmann-La Roche
Status de recrutamento
Faixa etária
Sexo
Fase do estudo
Este estudo avaliará a eficácia, segurança e farmacocinética de obinutuzumabe em comparação com placebo em pacientes com nefrite lúpica (LN) classe III ou IV da Sociedade Internacional de Nefrologia/Sociedade de Patologia Renal (ISN/RPS) quando adicionado ao tratamento padrão terapia consistindo de micofenolato de mofetil (MMF) e corticosteróides.
Principais Critérios de Inclusão:
Exclusão de chave Critérios:
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
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