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Assess the Efficacy and Safety of Multi-Target Therapy in Lupus Nephritis
This study is not yet open for participant recruitment.
Study NCT00876616   Information provided by Nanjing University School of Medicine
First Received: April 6, 2009   Last Updated: April 7, 2009   History of Changes
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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
 
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.

  1. 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).
  2. 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.
 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Lupus Nephritis
  • Drug: mycophenolate mofetil (MMF)
  • Drug: Tacrolimus (FK506)
  • Experimental: FK506
  • Experimental: MMF
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
370
August 2012
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients who signed written informed consent form
  2. aged between 18-60 years, female or male
  3. patients with a diagnosis of Systemic Lupus Erythematosus (SLE) according to the criteria of America Rheumatic Association, 1997
  4. 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
  5. 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
  6. Type III: RBC ≥ 50×104/ml

Exclusion Criteria:

  1. Patients who didn't sign written informed consent form
  2. Scr > 3.0 mg/dl (265.2 umol/L), eGFR < 30 ml/min/1.73m2 (Cockcroft-Gault)
  3. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
  4. Patients who have abnormal blood glucose, with a fasting blood glucose > 6.1 mmol/L or post meal blood glucose > 7.8 mmol/L
  5. Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), FK506 or MMF within 12 weeks
  6. Patients could not obey the protocol
  7. Patients who are known to be allergic to MMF\FK506\CTX\or steroid
  8. Patients who are pregnant or lactating
  9. Patients with severe infection or central nervous system symptoms
Both
18 Years to 60 Years
No
Contact: Haitao Zhang, Master 0086-25-80860218 hiataozh@yahoo.com.cn
China
 
 
NCT00876616
Zhihong Liu, Research Institute of Nephrology, Jinling Hospital
 
Nanjing University School of Medicine
  • Astellas Pharma Inc
  • Hoffmann-La Roche
Study Chair: Zhihong Liu, Master Nanjing University School of Medicine
Nanjing University School of Medicine
April 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.