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

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371319
• Other study ID #: HARECCTR0500018
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2006
• Last updated: July 1, 2014
• Start date: September 2005
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• tacrolimus
0.06-0.1 mg/kg/day
• mycophenolate mofetil
2-3 gm/day

Locations

Country	Name	City	State
China	Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission rate		month 6	No
Secondary	renal function deterioration, relapse and mortality		month 60	Yes