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

Tuen Mun Hospital

Status and phase: Completed; Phase 4

Conditions: Lupus Nephritis

Treatments: Drug: mycophenolate mofetil; Drug: tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00371319

HARECCTR0500018

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Tacrolimus

Active Comparator group

Description:

Tacrolimus treatment

Treatment:

Drug: tacrolimus

mycophenolate mofetil

Active Comparator group

Description:

mycophenolate mofetil

Treatment:

Drug: mycophenolate mofetil