Back to resultsComparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
tacrolimus
mycophenolate mofetil
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring lupus, nephritis, tacrolimus, mycophenolate mofetil
Eligibility Criteria
Inclusion Criteria:
- Patients who fulfill at least 4 of the ACR criteria for SLE
- Age >= 18 years
- Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
- Serum creatinine < 200 umol/L at the time of randomization
Exclusion Criteria:
- Patients who refuse to be randomized for treatment
- Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
- Serum creatinine >= 200 umol/L at the time of randomization
- Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
- Patients who are pregnant or plan for pregnancy within 12 months after randomization
Sites / Locations
- Tuen Mun Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tacrolimus
mycophenolate mofetil
Arm Description
Tacrolimus treatment
mycophenolate mofetil
Outcomes
Primary Outcome Measures
remission rate
Secondary Outcome Measures
renal function deterioration, relapse and mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00371319
Brief Title
Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Official Title
To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tuen Mun Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
lupus, nephritis, tacrolimus, mycophenolate mofetil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus
Arm Type
Active Comparator
Arm Description
Tacrolimus treatment
Arm Title
mycophenolate mofetil
Arm Type
Active Comparator
Arm Description
mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
Prograf
Intervention Description
0.06-0.1 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Other Intervention Name(s)
Cellcept
Intervention Description
2-3 gm/day
Primary Outcome Measure Information:
Title
remission rate
Time Frame
month 6
Secondary Outcome Measure Information:
Title
renal function deterioration, relapse and mortality
Time Frame
month 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who fulfill at least 4 of the ACR criteria for SLE
Age >= 18 years
Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
Serum creatinine < 200 umol/L at the time of randomization
Exclusion Criteria:
Patients who refuse to be randomized for treatment
Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
Serum creatinine >= 200 umol/L at the time of randomization
Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
Patients who are pregnant or plan for pregnancy within 12 months after randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CC MOK, MD, FRCP
Organizational Affiliation
Tuen Mun Hospital Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
32448782
Citation
Mok CC, Ho LY, Ying SKY, Leung MC, To CH, Ng WL. Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis. Ann Rheum Dis. 2020 Aug;79(8):1070-1076. doi: 10.1136/annrheumdis-2020-217178. Epub 2020 May 24.
Results Reference
derived
PubMed Identifier
25550339
Citation
Mok CC, Ying KY, Yim CW, Siu YP, Tong KH, To CH, Ng WL. Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up. Ann Rheum Dis. 2016 Jan;75(1):30-6. doi: 10.1136/annrheumdis-2014-206456. Epub 2014 Dec 30.
Results Reference
derived
Learn more about this trial
Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
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