Status:
COMPLETED
Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
Lupus Nephritis
Eligibility:
FEMALE
12-50 years
Phase:
NA
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 v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00298506
Start Date
September 1 2005
End Date
June 1 2009
Last Update
September 29 2011
Active Locations (2)
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1
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
2
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002