Lupus NephritisPhase 4NCT04145687
Metformin In Prevention of Lupus Nephritis
A Phase 4 study testing Metformin in people with Lupus Nephritis, run by RenJi Hospital at 1 site in China.
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%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2019to Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fangfang Sun, MD
Shanghai, Shanghai Municipality
Fangfang Sun, MD, +8615800901145, Fiona_rj@163.com
Ting Li, MD, +8613916927066, leeting007@163.com
About this study
Official title: Metformin In Prevention Of Lupus Nephritis In High Risk Patients
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.
- Conditions
- Lupus Nephritis
- Being tested
- Metformin
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 500mg tid
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Not described Receives: Drug: Metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of new-onset LN
Percentage of patients with new-onset lupus nephritis
Measured: 12 months
Secondary outcomes (4)
Change of SLEDAI score
Change of SLEDAI score during follow-up
Measured: 12 months
Change of Prednisone
Change of Prednisone during follow-up
Measured: 12 months
Time to onset of LN
Time to new-onset of lupus nephritis
Measured: 12 months
Change of proteinuria
Change of 24-hour proteinuria during follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Li, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145687
- Sponsor's protocol ID
- Met LN
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin In Prevention Of Lupus Nephritis In High Risk Patients
- ClinicalTrials.gov ID
- NCT04145687
- Acronym / sponsor ID
- Met LN
- Conditions
- Lupus Nephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin |
| Placebo | Placebo comparator | Drug: Metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 500mg tid | Drug | Metformin, Placebo |
Primary outcome
Prevention of new-onset LN
Time frame: 12 months
Percentage of patients with new-onset lupus nephritis
4 secondary outcomes
Change of SLEDAI score
Time frame: 12 months
Change of Prednisone
Time frame: 12 months
Time to onset of LN
Time frame: 12 months
Change of proteinuria
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Lupus Nephritis, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of new-onset LN (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.