Back to resultsMetformin In Prevention of Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Lupus Nephritis
Eligibility Criteria
Inclusion Criteria:
- New-onset of SLE (within 1 year)
- Meet the 1997 ACR criteria of SLE
- 1-year risk of developing LN higher than 50% based on LN prediction model.
- All the patients received standard care of therapy. (mycophenolate/azathioprine/cyclosporin/tacrolimus/methotrexate/leflunomide were allowed).
- Sign the informed consent.
Exclusion Criteria:
- Patients with kidney involvement at screening were excluded
- Patients with severe SLE were excluded, such as neuropsychiatric and cardiac involvement
- Cyclophosphamide or biologics were not allowed.
- Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 60ml/min;
- Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;
- Patients who diagnosed of diabetes mellitus;
- Pregnancy or lactation.
Sites / Locations
- Fangfang Sun, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Metformin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Prevention of new-onset LN
Percentage of patients with new-onset lupus nephritis
Secondary Outcome Measures
Change of SLEDAI score
Change of SLEDAI score during follow-up
Change of Prednisone
Change of Prednisone during follow-up
Time to onset of LN
Time to new-onset of lupus nephritis
Change of proteinuria
Change of 24-hour proteinuria during follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04145687
Brief Title
Metformin In Prevention of Lupus Nephritis
Official Title
Metformin In Prevention Of Lupus Nephritis In High Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Lupus nephritis (LN) is a main manifestation of systemic lupus erythematosus (SLE), which will largely effect the prognosis of SLE patients. Our previous 10-year data showed that the development of LN is most common in the first year of SLE, occupying about 17%. And our group has established a prediction model to predict the 1-year probability of LN for SLE patients without renal involvement. Our previous proof-of-concept trial and multicenter, randomized, double-blind, placebo-controlled trial indicated that metformin seemed to have potential to reduce the new-onset of LN in SLE patients (Unpublished data, in review). So the investigators tried to illustrate whether metformin has effect to prevent the development of lupus nephritis in high risk SLE patients based on LN prediction model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 500mg tid
Primary Outcome Measure Information:
Title
Prevention of new-onset LN
Description
Percentage of patients with new-onset lupus nephritis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of SLEDAI score
Description
Change of SLEDAI score during follow-up
Time Frame
12 months
Title
Change of Prednisone
Description
Change of Prednisone during follow-up
Time Frame
12 months
Title
Time to onset of LN
Description
Time to new-onset of lupus nephritis
Time Frame
12 months
Title
Change of proteinuria
Description
Change of 24-hour proteinuria during follow-up
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New-onset of SLE (within 1 year)
Meet the 1997 ACR criteria of SLE
1-year risk of developing LN higher than 50% based on LN prediction model.
All the patients received standard care of therapy. (mycophenolate/azathioprine/cyclosporin/tacrolimus/methotrexate/leflunomide were allowed).
Sign the informed consent.
Exclusion Criteria:
Patients with kidney involvement at screening were excluded
Patients with severe SLE were excluded, such as neuropsychiatric and cardiac involvement
Cyclophosphamide or biologics were not allowed.
Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 60ml/min;
Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;
Patients who diagnosed of diabetes mellitus;
Pregnancy or lactation.
Facility Information:
Facility Name
Fangfang Sun, MD
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangfang Sun, MD
Phone
+8615800901145
Email
Fiona_rj@163.com
First Name & Middle Initial & Last Name & Degree
Ting Li, MD
Phone
+8613916927066
Email
leeting007@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metformin In Prevention of Lupus Nephritis
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