A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis

A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis

The purpose of this protocol is to determine whether Tacrolimus and Prednisolone are effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse proliferative lupus nephritis

Inclusion Criteria:

• Biopsy-proven lupus nephritis WHO Class IV , IV+V
• Previously treated by three times over of i.v. cyclophosphamide or 6 months more duration of immunosuppressive treatments (azathioprine, MMF, cyclophosphamide p.o.) for the lupus nephritis
• spot urine Protein creatinine raio > 1.0
• RBC > 5 /HPF on microscopic examination of urine

Exclusion Criteria:

• previous treatment of cyclosporine A or tacrolimus
• serum Creatinine lever : over 300 mmol/dl
• allergy to the macrolide antibiotics
• other systemic organ damage