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

Phase 3

Completed

• Conditions: Kidney Diseases; Lupus Nephritis; Tacrolimus; Induction Phase; Maintenance Phase
• Interventions: Drug: tacrolimus (FK506); Drug: cyclophosphamide or azathioprine

• Registration Number: NCT00615173
• Lead Sponsor: Sun Yat-sen University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-14
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-27
• Last Update Posted: 2008-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tacrolimus (FK506)	tacrolimus(fk506) treatment in induction and maintenance phase
2	cyclophosphamide or azathioprine	intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase

Primary Outcome Measures

Name	Time	Method
Remission rate	2006-2008

Secondary Outcome Measures

Name	Time	Method
Renal function, proteinuria, relapse.	2006-2008

Trial Locations

Locations (1)

The 1st Affiliated Hospital, Sun Yet-sen University; 🇨🇳 Guangzhou, Guangdong, China