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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2014-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lupus Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tacrolimus

Tacrolimus treatment

Group Type ACTIVE_COMPARATOR

tacrolimus

Intervention Type DRUG

0.06-0.1 mg/kg/day

mycophenolate mofetil

Group Type ACTIVE_COMPARATOR

mycophenolate mofetil

Intervention Type DRUG

2-3 gm/day

Interventions

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tacrolimus

0.06-0.1 mg/kg/day

Intervention Type DRUG

mycophenolate mofetil

2-3 gm/day

Intervention Type DRUG

Other Intervention Names

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Prograf Cellcept

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No