Lupus Nephritis Clinical Trial
Official title:
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
Verified date | December 2023 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with TAC and corticosteroids combined with MMF.
Status | Active, not recruiting |
Enrollment | 130 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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)] | Sustained RR defined as satisfying all of the following criteria:
proteinuria improved by >50% compared with baseline 24-hr urine protein <1 g serum creatinine not higher than 15% above baseline level 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 |
96 weeks |
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