Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    200
  • sponsor
    The University of Hong Kong
Updated on 26 January 2021
corticosteroids
tacrolimus
proteinuria
mycophenolate
hematuria
nephritis

Summary

Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with TAC and corticosteroids combined with MMF.

Description

There is accumulating evidence that tacrolimus (TAC) could serve as an effective medication for the treatment of lupus nephritis (LN). TAC is a calcineurin inhibitor, which is a key component in first-line combination immunosuppressive regimens after kidney transplantation, based on its proven efficacy in the prevention and treatment of allograft rejection and acceptable tolerability profile. Although it primarily targets T lymphocyte activation, its immunosuppressive actions encompass multiple immune response pathways due to the complex interactions between different cellular and soluble immune mediators. Moreover, the effect of calcineurin inhibitors on podocyte morphology and function, independent of their immunosuppressive effect, has translated into therapeutic efficacy in the treatment of proteinuric glomerular diseases such as membranous nephropathy and focal segmental glomerulosclerosis. Recent data from short-term studies showed that combination immunosuppressive regimens that included TAC and corticosteroids with or without mycophenolate mofetil (MMF) appeared at least as effective as other standard-of-care treatments for Class III/IVV LN, and the inclusion of TAC might lead to more effective suppression of proteinuria. There is also preliminary data on its favorable tolerability when used as long-term maintenance treatment. This study aims to examine the role of TAC combined with corticosteroids, in comparison with the most commonly used standard-of-care treatment MMF plus corticosteroids, in the management of lupus nephritis.

Details
Condition Glomerulonephritis, SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
Treatment mycophenolate mofetil, Tacrolimus
Clinical Study IdentifierNCT02630628
SponsorThe University of Hong Kong
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Lupus Nephritis?
Do you have any of these conditions: Glomerulonephritis or SYSTEMIC LUPUS ERYTHEMATOSUS or Lupus Nephritis?
Biopsy-proven LN Class III/IVV (ISN/RPS 2003), with biopsy performed within 12 weeks of randomization
Positive anti-dsDNA
Active LN with proteinuria (urine protein/creatinine ratio >1.0 or 24-hr urine protein >1.0 g at baseline), with or without hematuria
Both 'incident' (i.e. new) patients and 'flare' patients can be included

Exclusion Criteria

Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney
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
Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli
CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own
Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease)
Treatment with prednisolone (or prednisone, or equivalent) at >20 mg/D for over 4 weeks within the past 3 months
Treatment with MMF at >1.5 g/D for over 4 weeks within the past 3 months
Known hypersensitivity or intolerability to prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day
Subjects who are already on treatment with TAC, cyclosporine or any other calcineurin inhibitor for over 4 weeks within the past 12 months
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)
Uncontrolled hypertension with systolic BP >160 mmHg or diastolic BP >95 mmHg
Women who are pregnant or breastfeeding
Women with childbearing potential or their male partners, who refuse to use an effective birth control method
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