Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis

Summary

The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).

To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).

Conditions

• Kidney Diseases
• Lupus Nephritis
• Tacrolimus
• Induction Phase
• Maintenance Phase

Interventions

DRUG

tacrolimus (FK506)

Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;

DRUG

cyclophosphamide or azathioprine

Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.

Sponsors & Collaborators

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Xue Qing Yu, MD · Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

• Ping Fu, MD · Department of Nephrology, West China Hospital of Sichuan University

• Yun Hua Liao, MD · Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University

• Jin li Zhang, MD · Department of nephrology, People's Hospital of Yunnan Province

• Jian Chen, MD · Department of Nephrology, Fuzhou Military General Hospital

• Tan Qi Lou, MD · Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University

• Yao zhong Kong, MD · Department of Nephrology, 1st People's Hospital of Foshan

• Jun zhou Fu, MD · Department of Nephrology,1st People's Hospital of Guangzhou

• Wei Shi, MD · Department of Nephrology, People's Hospital Guangdong Provincial

• Zheng rong Liu, MD · Department of Nephrology, Nanfang Hospital of Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2008-09-30

Completion

2008-09-30

Countries

• China

Study Locations