Metformin In Prevention of Lupus Nephritis
Metformin In Prevention Of Lupus Nephritis In High Risk Patients
1 other identifier
interventional
30
1 country
1
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trial indicated that metformin seemed to have potential to reduce the new-onset of LN in SLE patients (Unpublished data, in review).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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedOctober 31, 2019
October 1, 2019
1.6 years
October 22, 2019
October 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Prevention of new-onset LN
Percentage of patients with new-onset lupus nephritis
12 months
Secondary Outcomes (4)
Change of SLEDAI score
12 months
Change of Prednisone
12 months
Time to onset of LN
12 months
Change of proteinuria
12 months
Study Arms (2)
Metformin
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- New-onset of SLE (within 1 year)
- Meet the 1997 ACR criteria of SLE
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Fangfang Sun, MD
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
October 22, 2019
First Posted
October 31, 2019
Study Start
November 1, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2022
Last Updated
October 31, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share