Este estudio de 2 brazos evaluó la eficacia del micofenolato de mofetilo (MMF; CellCept) comparado con ciclofosfamida para inducir una respuesta en pacientes con nefritis lúpica, y la eficacia a largo plazo del MMF comparado con azatioprina para mantener la remisión y la función renal. Los pacientes fueron aleatorizados para recibir MMF (1,5 g dos veces al día [bid]) o ciclofosfamida (0,5-1,0 g/m\^2 en pulsos mensuales) en la fase de inducción. Los pacientes que cumplieron los criterios de respuesta fueron re-aleatorizados para entrar en la fase de mantenimiento, recibiendo MMF (1 g bid) o azatioprina (2 mg/kg/día).
Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.
Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions. Dosing was started at 0.75 g/m\^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m\^2. The target dose was 1.0 g/m\^2, but doses were titrated by 0.25 g/m\^2 increments to maintain nadir leukocyte count between 2500-4000/mm\^3.
2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.
Placebo capsules matching Azathioprine taken orally once a day.
Placebo tablets matching Mycophenolate mofetil taken orally twice daily.
Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
Buenos Aires, Argentina
Buenos Aires, Argentina
Córdoba, Argentina
San Isidro, Argentina
San Miguel de Tucumán, Argentina