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Metformin In Prevention of Lupus Nephritis

NCT ID: NCT04145687

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2022-06-30

Brief Summary

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trial indicated that metformin seemed to have potential to reduce the new-onset of LN in SLE patients (Unpublished data, in review).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

Detailed Description

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Conditions

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Lupus Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Metformin

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 500mg tid

Placebo

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 500mg tid

Interventions

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Metformin

Metformin 500mg tid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ting Li

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fangfang Sun, MD

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Facility Contacts

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Fangfang Sun, MD

Role: primary

Ting Li, MD

Role: backup

Other Identifiers

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Met LN

Identifier Type: -

Identifier Source: org_study_id