Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

Phase 4

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: tacrolimus; Drug: mycophenolate mofetil

• Registration Number: NCT00371319
• Lead Sponsor: Tuen Mun Hospital

Brief Summary

The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.

Detailed Description

Patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. Efficacy and adverse effects will be compared.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-09-01
• Study First Submitted QC: 2006-09-01
• Study First Posted: 2006-09-04
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients who fulfill at least 4 of the ACR criteria for SLE
2. Age >= 18 years
3. Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
4. Serum creatinine < 200 umol/L at the time of randomization

Exclusion Criteria

1. Patients who refuse to be randomized for treatment
2. Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
3. Serum creatinine >= 200 umol/L at the time of randomization
4. Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
5. Patients who are pregnant or plan for pregnancy within 12 months after randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus	tacrolimus	Tacrolimus treatment
mycophenolate mofetil	mycophenolate mofetil	mycophenolate mofetil

Primary Outcome Measures

Name	Time	Method
remission rate	month 6

Secondary Outcome Measures

Name	Time	Method
renal function deterioration, relapse and mortality	month 60

Trial Locations

Locations (1)

Tuen Mun Hospital; 🇨🇳 Hong Kong, China