Last updated on May 2018

Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lupus Nephritis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Biopsy-proven LN Class III/IVV (ISN/RPS 2003), with biopsy performed within 12 weeks of randomization.
  2. Positive anti-dsDNA.
  3. Active LN with proteinuria (urine protein/creatinine ratio >1.0 or 24-hr urine protein >1.0 g at baseline), with or without hematuria.
  4. Both 'incident' (i.e. new) patients and 'flare' patients can be included.

Exclusion Criteria:

  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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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