Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
- Conditions
- Lupus Nephritis
- Interventions
- Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma)
- Registration Number
- NCT01206569
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
- Age over 18 with informed consent.
- Fulfill the revised American College of Rheumatology criteria for SLE
- Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
- Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
- NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine <15% above the base-line value.
- Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.
- Abnormal liver function tests
- Hepatitis B surface antigen or hepatitis C antibody positive
- Diabetic
- Receiving NSAID or other agents known to influence urinary
- Protein excretion
- Allergic or intolerant to macrolide antibiotics or tacrolimus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description advagraf Long-acting tacrolimus (Advagraf, Astellas Pharma) Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.
- Primary Outcome Measures
Name Time Method overall clinical response 6 months complete response is defined as urinary protein \< 0.5 g/day, with normal urinary sediment, normal serum albumin, and serum creatinine \< 15% above the base-line value. Partial response is defined as urinary protein between 0.6 and 2.9 g/day, with a serum albumin \> 30 g/dL, and stable renal function. No response is defined as urinary protein \> 3 g/day or a value of 0.6 to 2.9 g/day but serum albumin \< 30 g/dL, an increase in serum creatinine ≥ 50 µmol/l or 15% above the base-line value, or the discontinuation of treatment due to side effects.
- Secondary Outcome Measures
Name Time Method renal function 6 months change in SLEDAI score 6 months 24-hour urinary protein excretion 6 months development of lupus flare (renal or non-renal) 6 months
Trial Locations
- Locations (1)
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong
Prince of Wales Hospital🇭🇰Shatin, Hong Kong