CompletedPhase 3

Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis

Hong Kong130 participantsStarted 2015-12-05

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Biopsy-proven LN Class III/IV±V (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.
✓. Males or females aged 18 to 75 years inclusive at the time of screening.

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.

What they're measuring

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)]

Timeframe: 96 weeks

Trial details

NCT IDNCT02630628

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-27

View on ClinicalTrials.gov More Lupus Nephritis trials