Metformin In Prevention of Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

Metformin In Prevention Of Lupus Nephritis In High Risk Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04145687
• Other study ID #: Met LN
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2019
• Est. completion date: June 2022

Study information

• Verified date: October 2019
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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trial indicated that metformin seemed to have potential to reduce the new-onset of LN in SLE patients (Unpublished data, in review).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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Metformin
Metformin 500mg tid

Locations

Country	Name	City	State
China	Fangfang Sun, MD	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of new-onset LN	Percentage of patients with new-onset lupus nephritis	12 months
Secondary	Change of SLEDAI score	Change of SLEDAI score during follow-up	12 months
Secondary	Change of Prednisone	Change of Prednisone during follow-up	12 months
Secondary	Time to onset of LN	Time to new-onset of lupus nephritis	12 months
Secondary	Change of proteinuria	Change of 24-hour proteinuria during follow-up	12 months