Tacrolimus Versus Cyclophosphamide as Treatment for Lupus Nephritis

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In this comparative open-label cohort study, the investigators compared the efficacy and safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC.

Methods: Forty patients with diffuse proliferative or membranous were recruited for this trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine (>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone followed by azathioprine (50mg/day）for 6 months (CYC group).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: Cyclophosphamide; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• SLE patients:diagnosis based on American Rheumatism Association criteria;

• renal biopsy-proven active LN (diffuse proliferative and membranous lupus nephritis, class IV, V, V+IV and/or V+III, according to the ISN/RPS 2003 classification13)

• urinary protein excretion of at least 2.0 g per 24 h

• serum creatinine less than 221 µmol/dL (2.5mg/dL)

• creatinine clearance more than 30 mL/min/1.73m2

Exclusion Criteria:

• pregnant or lactating

• previous treatment with cyclosporine, mycophenolate mofetil treatment for at least two weeks in the previous three months

• known allergies to calcineurin inhibitors

• severe infection or illness

• symptoms of a central nervous system disorder

• alanine aminotransferase more than 100U/L

• evidence of active hepatitis

• fasting blood glucose more than 6.2 mmol/L

• 2 h post-meal blood glucose more than 11.1mmol/L