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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00615173

Enrollment

Registered

2008-02-14

Start date

2006-07-31

Completion date

2008-09-30

Last updated

2008-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Tacrolimus, lupus nephritis

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).

Interventions

DRUGtacrolimus (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;

DRUGcyclophosphamide or azathioprine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

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 .

Design outcomes

Primary

Measure	Time frame
Remission rate	2006-2008

Secondary

Measure	Time frame
Renal function, proteinuria, relapse.	2006-2008

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026