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Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis

This study has been completed.
Sponsor:
Collaborators:
West China Hospital
Ruijin Hospital
Jiangsu Province Hospital
RenJi Hospital
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00876616
First received: April 6, 2009
Last updated: May 21, 2012
Last verified: May 2012
History of Changes

April 6, 2009
May 21, 2012
April 2009
May 2011   (final data collection date for primary outcome measure)
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
 
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lupus Nephritis
  • Drug: mycophenolate mofetil (MMF)
    MMF 1.0 g/d
    Other Name: MMF
  • Drug: Tacrolimus (FK506)
    FK506 4 mg/d
    Other Name: FK506
  • Experimental: Tacroliums
    FK506
    Intervention: Drug: Tacrolimus (FK506)
  • Experimental: mycophenolate mofetil
    MMF
    Intervention: Drug: mycophenolate mofetil (MMF)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
362
February 2012
May 2011   (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 information is only displayed when the study is recruiting subjects
China
 
NCT00876616
NJCT-0901
Yes
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
Zhi-Hong Liu, M.D.
  • West China Hospital
  • Ruijin Hospital
  • Jiangsu Province Hospital
  • RenJi Hospital
Study Chair: Zhihong Liu, Master Nanjing University School of Medicine
Nanjing University School of Medicine
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP