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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT00615173

Collaborator

(none)

Enrollment

Location

Arms

26.1

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases Lupus Nephritis Tacrolimus Induction Phase Maintenance Phase	Drug: tacrolimus (FK506) Drug: cyclophosphamide or azathioprine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 tacrolimus(fk506) treatment in induction and maintenance phase	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;
Active Comparator: 2 intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase	Drug: cyclophosphamide or azathioprine Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.

Arm

Intervention/Treatment

Experimental: 1

tacrolimus(fk506) treatment in induction and maintenance phase

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;

Active Comparator: 2

intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase

Drug: cyclophosphamide or azathioprine

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

Outcome Measures

Primary Outcome Measures

Remission rate [2006-2008]

Secondary Outcome Measures

Renal function, proteinuria, relapse. [2006-2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects of either sex, 14-65 years of age;
Diagnosis of SLE according to the ACR criteria(1997);
Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
Class IV LN: proteinuria >1g/24hr or Scr>115umol/L;
Class III or V LN: proteinuria >2g/24hr or Scr>115umol/L;
Provision of written informed consent by subject or guardian.

Exclusion Criteria:

Inability or unwillingness to provide written informed consent ;
Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
Pregnancy, nursing or use of a non-reliable method of contraception;
Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
Previous kidney transplant or planted transplant;
Scr > 4mg/dl (353umol/L);
Active hepatitis, with liver dysfunction;
Diagnosed DM;
Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The 1st Affiliated Hospital, Sun Yet-sen University	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Xue Qing Yu, MD, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Ping Fu, MD, Department of Nephrology, West China Hospital of Sichuan University
Principal Investigator: Yun Hua Liao, MD, Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University
Principal Investigator: Jin li Zhang, MD, Department of nephrology, People's Hospital of Yunnan Province
Principal Investigator: Jian Chen, MD, Department of Nephrology, Fuzhou Military General Hospital
Principal Investigator: Tan Qi Lou, MD, Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
Principal Investigator: Yao zhong Kong, MD, Department of Nephrology, 1st People's Hospital of Foshan
Principal Investigator: Jun zhou Fu, MD, Department of Nephrology,1st People's Hospital of Guangzhou
Principal Investigator: Wei Shi, MD, Department of Nephrology, People's Hospital Guangdong Provincial
Principal Investigator: Zheng rong Liu, MD, Department of Nephrology, Nanfang Hospital of Southern Medical University