Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

1. Biopsy-proven LN Class III/IV±V (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