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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000025328
• Date of registration: 25/12/2016
• Prospective Registration: No
• Primary sponsor: The University of Hong Kong
• Public 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
• Scientific 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 - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis
• Date of first enrolment: 2015/12/05
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029135
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan,Asia(except Japan)

Contacts

• Name: Tak-Mao Daniel Chan
• Affiliation: The University of Hong Kong Department of Medicine

• Name: Tak-Mao Daniel Chan
• Affiliation: The University of Hong Kong Department of Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 18years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

systemic lupus erythematosus

Intervention(s)

Tacrolimus
Mycophenolate Mofetil

Primary Outcome(s)

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)] [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ] Sustained RR defined as satisfying all of the following criteria: 1. proteinuria improved by >50% compared with baseline 2. 24-hr urine protein <1 g 3. serum creatinine not higher than 15% above baseline level 4. 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

Secondary ID(s)

NCT02630628

Source(s) of Monetary Support

The University of Hong Kong

Ethics review

Status: YES
Approval date: 02/09/2015
Contact:

Results

• Results available: Yes
• Date Completed: 31/12/2021