Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis

Korábbi kezelés

• CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own.
• Treatment with prednisolone (or prednisone, or equivalent) at ≥20 mg/D for over 4 weeks within the past 3 months.
• Treatment with MMF at \>1.5 g/D for over 4 weeks within the past 3 months.
• Subjects who are already on treatment with TAC, cyclosporine or any other calcineurin inhibitor on the day of screening; or have received treatment with TAC, cyclosporine or other calcineurin inhibitor for over 4 weeks within the past 6 months.
• Treatment with cyclophosphamide, leflunomide, or methotrexate for over 2 weeks, or use of biological agent(s) regardless of duration, within the past 6 months (Note: prior use of azathioprine, mizoribine, intravenous immunoglobulins and anti-malarials is allowed).

Más betegség

• Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney.
• Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease).
• Known hypersensitivity or intolerability to prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day.
• Uncontrolled hypertension with systolic BP \>160 mmHg or diastolic BP \>95 mmHg.

Laborértékek

• Estimated glomerular filtration rate (eGFR by MDRD) ≤20 mL/min per 1.73 m2 or serum creatinine ≥300 micromol/L (3.39 mg/dL) at screening.

Egyéb

• Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli.
• Women who are pregnant or breastfeeding.
• Women with childbearing potential or their male partners, who refuse to use an effective birth control method

• Biopsy-proven LN Class III/IV±V (ISN/RPS 2003), with biopsy performed within 12 weeks of randomization.
• Positive anti-dsDNA.
• Active LN with proteinuria (urine protein/creatinine ratio ≥1.0 or 24-hr urine protein ≥1.0 g at baseline), with or without hematuria.
• Both 'incident' (i.e. new) patients and 'flare' patients can be included.
• Males or females aged 18 to 75 years inclusive at the time of screening.