NCT00615173View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Kidney DiseasesLupus NephritisTacrolimusInduction PhaseMaintenance Phase
Interventions
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;

DRUG

cyclophosphamide or azathioprine

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

Trial Locations (1)

510080

The 1st Affiliated Hospital, Sun Yet-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER

NCT00615173 - Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis | Biotech Hunter | Biotech Hunter