Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis

Korábbi kezelés

• Previous or planned kidney transplant.
• Patients with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study.

Más betegség

• Patients with active serious digestive system disease, including infrequent cases of gastrointestinal tract ulceration with hemorrhage or perforation.

Laborértékek

• Were receiving continuous dialysis or GFR < 30 mL/min/1.73 m2 within 3 months prior to the start of study.

• Aged ≥ 20 years and ≤ 75 years at screening.
• Patients with written informed consent form.
• Male or female diagnosed with SLE.
• Confirmed diagnosis of LN by physician. Diagnosis of LN was defined as:
  • Kidney biopsy within 1 year, with histological diagnosis of LN (class III/IV/V)
  • Laboratory evidence of active nephritis: spot UPCR>0.5, and/or proteinuria > 0.5 g/24 hours, and/or greater than 3+ by dipstick, and/or cellular casts.
• Patients with LN who received EC-MPS for the first time. The patients who switched from other treatment and treatment naive patients (did not receive any treatment before) could be included in this study.
• Women of childbearing potential must have used effective contraception before beginning EC MPS therapy, during therapy, and for six weeks after their last dose of EC MPS.