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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Tacrolimus; Kidney Diseases; Induction Phase; Lupus Nephritis; Maintenance Phase

Treatments: Drug: tacrolimus (FK506); Drug: cyclophosphamide or azathioprine

Study type: Interventional

Funder types: Other

Identifiers

NCT00615173

SYSU-PRGLN-001

Details and patient eligibility

About

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).

Enrollment: 81 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

1

Experimental group

Description:

tacrolimus(fk506) treatment in induction and maintenance phase

Treatment:

Drug: tacrolimus (FK506)

2

Active Comparator group

Description:

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

Treatment:

Drug: cyclophosphamide or azathioprine