Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)
Lupus Nephritis
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring Tacrolimus, Mycophenolate mofetil, Cyclophosphamide, Lupus nephritis, Treatment
Eligibility Criteria
Inclusion Criteria: Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN). Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI< 4,Scr< 3 mg/dl. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment. Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups. Exclusion Criteria: Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months. Patients with serum creatinine ≥ 3 mg/dl(265 μmol/L). Patients with severe infection or central nervous system symptoms. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis. Patients who have abnormal blood glucose, with a fasting blood glucose > 6.2 mmol/L or post meal blood glucose > 11.2 mmol/L. Patients who are pregnant or lactating. Patients who are known to be allergic to a macrolide.
Sites / Locations
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
- Research Institute of Nephrology, Jinling Hospital
Arms of the Study
Arm 1
Active Comparator
FK506+MMF