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

This study is not yet open for participant recruitment.

Verified by Nanjing University School of Medicine, April 2009

First Received: April 6, 2009 Last Updated: April 7, 2009 History of Changes

Sponsors and Collaborators:	Nanjing University School of Medicine Astellas Pharma Inc Hoffmann-La Roche
Information provided by:	Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00876616

Purpose

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.

Condition	Intervention
Lupus Nephritis	Drug: mycophenolate mofetil (MMF) Drug: Tacrolimus (FK506)

Drug Information available for: Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	370
Study Start Date:	April 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tacroliums: Experimental FK506	Drug: Tacrolimus (FK506) FK506 4 mg/d
mycophenolate mofetil: Experimental MMF	Drug: mycophenolate mofetil (MMF) MMF 1.0 g/d

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876616

Contacts

Contact: Haitao Zhang, Master

0086-25-80860218

hiataozh@yahoo.com.cn

Locations

China, Jiangsu
Research Institute of Nephrology,Jinling Hospital
Nanjing, Jiangsu, China, 210002

Sponsors and Collaborators

Nanjing University School of Medicine

Astellas Pharma Inc

Hoffmann-La Roche

Investigators

Study Chair:

Zhihong Liu, Master

Nanjing University School of Medicine

More Information

No publications provided

Responsible Party:	Research Institute of Nephrology, Jinling Hospital ( Zhihong Liu )
Study ID Numbers:	NJCT-0901
Study First Received:	April 6, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00876616 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Glomerulonephritis
Autoimmune Diseases
Immunologic Factors
Lupus Nephritis
Lupus
Tacrolimus
Immunosuppressive Agents

Urologic Diseases
Lupus Erythematosus, Systemic
Nephritis
Connective Tissue Diseases
Mycophenolate mofetil
Kidney Diseases

Additional relevant MeSH terms:

Glomerulonephritis
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Lupus Nephritis
Physiological Effects of Drugs
Tacrolimus
Immunosuppressive Agents

Pharmacologic Actions
Urologic Diseases
Lupus Erythematosus, Systemic
Nephritis
Connective Tissue Diseases
Mycophenolate mofetil
Kidney Diseases

ClinicalTrials.gov processed this record on May 07, 2009