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

• Status: Unknown status
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Tacrolimus

Criteria

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