Lupus Nephritis
Conditions
Keywords
Tacrolimus, Mycophenolate mofetil, Cyclophosphamide, Lupus nephritis, Treatment
Brief summary
This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.
Detailed description
1. To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN. 2. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN. 3. To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.
Interventions
DRUGMultitherapy
Tacrolimus,4mg/d, MMF 1.0g/d
Sponsors
Nanjing University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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). 2. 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. 3. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment. 4. 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
1. Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months. 2. Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L). 3. Patients with severe infection or central nervous system symptoms. 4. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis. 5. Patients who have abnormal blood glucose, with a fasting blood glucose \> 6.2 mmol/L or post meal blood glucose \> 11.2 mmol/L. 6. Patients who are pregnant or lactating. 7. Patients who are known to be allergic to a macrolide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses | 18 months |
Countries
China
Outcome results
None listed