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

Primary Purpose

Kidney Diseases, Lupus Nephritis, Tacrolimus

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

tacrolimus (FK506)

cyclophosphamide or azathioprine

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring Tacrolimus, lupus nephritis

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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 .

Sites / Locations

The 1st Affiliated Hospital, Sun Yet-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

tacrolimus(fk506) treatment in induction and maintenance phase

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

Outcomes

Primary Outcome Measures

Remission rate

Secondary Outcome Measures

Renal function, proteinuria, relapse.

Full Information

NCT ID

NCT00615173

First Posted

February 1, 2008

Last Updated

October 27, 2008

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT00615173

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Tacrolimus, lupus nephritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

tacrolimus(fk506) treatment in induction and maintenance phase

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

tacrolimus (FK506)

Intervention Description

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;

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide or azathioprine

Intervention Description

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

Primary Outcome Measure Information:

Title

Remission rate

Time Frame

2006-2008

Secondary Outcome Measure Information:

Title

Renal function, proteinuria, relapse.

Time Frame

2006-2008

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 .

Overall Study Officials: