A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis
- Conditions
- systemic lupus erythematosus
- Registration Number
- JPRN-UMIN000025328
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Not provided
1. Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney. 2. 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. 3. Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli. 4. CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own. 5. Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease). 6. Treatment with prednisolone (or prednisone, or equivalent) at >20 mg/D for over 4 weeks within the past 3 months. 7. Treatment with MMF at >1.5 g/D for over 4 weeks within the past 3 months. 8. Known hypersensitivity or intolerability to prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day. 9. Subjects who are already on treatment with TAC, cyclosporine or any other calcineurin inhibitor for over 4 weeks within the past 12 months. 10. 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). 11. Uncontrolled hypertension with systolic BP >160 mmHg or diastolic BP >95 mmHg. 12. Women who are pregnant or breastfeeding. 13. Women with childbearing potential or their male partners, who refuse to use an effective birth control method
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of combined corticosteroids and TAC compared to combined corticosteroids and MMF in achieving sustained renal response (RR) in patients with active lupus nephritis [Class III/IV+/-V (LN)] [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ] Sustained RR defined as satisfying all of the following criteria: 1. proteinuria improved by >50% compared with baseline 2. 24-hr urine protein <1 g 3. serum creatinine not higher than 15% above baseline level 4. no occurrence of disease flare, defined as receiving 'rescue' increase of immunosuppressive therapy with any one of the following - requiring increase of prednisolone (or prednisone, or equivalent) dose to above 15 mg/D for 4 weeks or longer, change of originally assigned immunosuppressive agent, or addition of immunosuppressive medications prohibited in protocol
- Secondary Outcome Measures
Name Time Method