NCT02630628CompletedPhase 3
Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2025
Brief summary (registry, in English)
Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with tacrolimus and corticosteroids combined with mycophenolate mofetil.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 5 Dec 2015
- Start date
- 5 Dec 2015
- Primary completion date
- 27 Dec 2024
- Lead sponsor
- The University of Hong Kong
- Diseases
- Lupus (SLE)
- NCT number
- NCT02630628
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 130
- From 5 Dec 2015 to the primary completion date, 27 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own.
- 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.
- Subjects who are already on treatment with TAC, cyclosporine or any other calcineurin inhibitor on the day of screening; or have received treatment with TAC, cyclosporine or other calcineurin inhibitor for over 4 weeks within the past 6 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).
Other illness
- Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney.
- Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease).
- Known hypersensitivity or intolerability to prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day.
- Uncontrolled hypertension with systolic BP \>160 mmHg or diastolic BP \>95 mmHg.
Lab values
- 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.
Other
- Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli.
- Women who are pregnant or breastfeeding.
- Women with childbearing potential or their male partners, who refuse to use an effective birth control method
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.