April 6, 2009 |
April 7, 2009 |
April 2009 |
To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ] |
Same as current |
Complete list of historical versions of study NCT00876616 on ClinicalTrials.gov Archive Site |
To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ] |
Same as current |
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Assess the Efficacy and Safety of Multi-Target Therapy in Lupus Nephritis |
An Multi-Site, Open, Prospective Study to Assess the Efficacy and Safety of Multi-Target Therapy in the Treatment of Class III, IV, V+III and V+IV Lupus Nephritis |
The purpose of this study is to assess the efficacy and safety of multi-target therapy in the treatment of class III, IV, V+III and V+IV lupus nephritis. |
- To assess the efficacy of FK506 combined with MMF vs intravenous cyclophosphamide (CTX) pulses in treatment of class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ Lupus Nephritis (LN).
- To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN.
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Interventional |
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Lupus Nephritis |
- Drug: mycophenolate mofetil (MMF)
- Drug: Tacrolimus (FK506)
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- Experimental: FK506
- Experimental: MMF
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Not yet recruiting |
370 |
August 2012 |
October 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patients who signed written informed consent form
- aged between 18-60 years, female or male
- patients with a diagnosis of Systemic Lupus Erythematosus (SLE) according to the criteria of America Rheumatic Association, 1997
- Patients diagnosed according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy within 3 weeks, CI < 3
- proteinuria ≥ 1.5 g/24h, or active urine sediment in type(RBC > 10×104/ml,or WBC > 5 /HP) IV, V+IV and V+III LN
- Type III: RBC ≥ 50×104/ml
Exclusion Criteria:
- Patients who didn't sign written informed consent form
- Scr > 3.0 mg/dl (265.2 umol/L), eGFR < 30 ml/min/1.73m2 (Cockcroft-Gault)
- 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 > 6.1 mmol/L or post meal blood glucose > 7.8 mmol/L
- Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), FK506 or MMF within 12 weeks
- Patients could not obey the protocol
- Patients who are known to be allergic to MMF\FK506\CTX\or steroid
- Patients who are pregnant or lactating
- Patients with severe infection or central nervous system symptoms
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Both |
18 Years to 60 Years |
No |
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China |
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NCT00876616 |
Zhihong Liu, Research Institute of Nephrology, Jinling Hospital |
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Nanjing University School of Medicine |
- Astellas Pharma Inc
- Hoffmann-La Roche
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Study Chair: |
Zhihong Liu, Master |
Nanjing University School of Medicine |
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Nanjing University School of Medicine |
April 2009 |