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

Kidney Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615173
• Other study ID #: SYSU-PRGLN-001
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2008
• Last updated: October 27, 2008
• Start date: July 2006
• Est. completion date: September 2008

Study information

• Verified date: October 2008
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects of either sex, 14-65 years of age;

2. Diagnosis of SLE according to the ACR criteria(1997);

3. Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;

4. Class IV LN: proteinuria >1g/24hr or Scr>115umol/L;

5. Class III or V LN: proteinuria >2g/24hr or Scr>115umol/L;

6. Provision of written informed consent by subject or guardian.

Exclusion Criteria:

1. Inability or unwillingness to provide written informed consent ;

2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;

3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;

4. Pregnancy, nursing or use of a non-reliable method of contraception;

5. 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;

6. Previous kidney transplant or planted transplant;

7. Scr > 4mg/dl (353umol/L);

8. Active hepatitis, with liver dysfunction;

9. Diagnosed DM;

10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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;
• cyclophosphamide or azathioprine
Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate		2006-2008	Yes
Secondary	Renal function, proteinuria, relapse.		2006-2008	Yes