Lupus NephritisNCT02435368
The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and LPS on IL-1β Secretion by Mononuclear
An observational study of Lupus Nephritis, run by The Third Affiliated Hospital of Southern Medical University at 1 site in China.
Trial summary
To determine the mechanisms and significances of synergistic effects of mycophenolic acid and LPS on IL-1β secretion by mononuclear Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- mycophenolic acid
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Mar 2016
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Volunteers,age 18-60.
Who may be able to join
- Healthy Volunteers，age 18-60.
Who cannot join
- Don't agree with informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510630
erwei Sun, doctor, +86 020-62784421, ewsun@263.net
xuechan Huang, doctor, +86 15521116926, flycicada@163.com
About this study
Official title: The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and Lipopolysaccharide on Interleukin-1β Secretion by Mononuclear
To determine the mechanisms and significances of synergistic effects of mycophenolic acid and LPS on IL-1β secretion by mononuclear
Read the detailed description
Mycophenolate mofetil (MMF), which inhibits T and B lymphocyte proliferation, is widely used to treat a variety of autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN). We are the first to show that mycophenolic acid (MPA), the active metabolite of MMF, in association with lipopolysaccharide (LPS), is able to promote the secretion of interleukin (IL)-1β, which contradicts the traditional conception that immunosuppressants inhibit the secretion of inflammatory factors.
In this study, we first determined the effects of MPA in association with LPS on IL-1β production. Then, we explored whether the synergized effect on IL-1β production was mediated through the nuclear factor （NF）-κB pathway that produces more pro-IL-1β, or through the triggering of NLRP3 inflammasome that leads to enhanced activation of caspase-1 and accelerated degradation of pro-IL-1β into mature IL-1β.
This study is not only conducive to clarify the mechanisms, signal transduction pathways and potential clinical significances of IL-1β production in LPS and MPA combined treatment, but also to provide experimental data as well as theoretical rationales for more effective and more logical immunosuppressive protocols.
- Conditions
- Lupus Nephritis
- Being tested
- mycophenolic acid
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycophenolic acidDrug
Also called mycophenolate mofetil
Monocytes were co-cultured with LPS and/or MPA.After 12 hours, the supernatants were harvested and stored at -80°C for ELISA.
What is being measured
The primary outcome is the main question the study is designed to answer.
mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015 (estimated)
- Study completionMar 2016 (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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Southern Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xuechan Huang, The Third Affiliated Hospital of Southern Medical University
- Investigators
- erwei Sun, doctor, Study director, Third Affiliated Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435368
- Sponsor's protocol ID
- 201501001
- Status last verified
- Apr 2015
- First submitted
- 25 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and Lipopolysaccharide on Interleukin-1β Secretion by Mononuclear
- ClinicalTrials.gov ID
- NCT02435368
- Acronym / sponsor ID
- 201501001
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Southern Medical UniversityOther government
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 6 May 2015 (estimated)
- 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.
To determine the mechanisms and significances of synergistic effects of mycophenolic acid and LPS on IL-1β secretion by mononuclear
Detailed description
Mycophenolate mofetil (MMF), which inhibits T and B lymphocyte proliferation, is widely used to treat a variety of autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN). We are the first to show that mycophenolic acid (MPA), the active metabolite of MMF, in association with lipopolysaccharide (LPS), is able to promote the secretion of interleukin (IL)-1β, which contradicts the traditional conception that immunosuppressants inhibit the secretion of inflammatory factors.
In this study, we first determined the effects of MPA in association with LPS on IL-1β production. Then, we explored whether the synergized effect on IL-1β production was mediated through the nuclear factor （NF）-κB pathway that produces more pro-IL-1β, or through the triggering of NLRP3 inflammasome that leads to enhanced activation of caspase-1 and accelerated degradation of pro-IL-1β into mature IL-1β.
This study is not only conducive to clarify the mechanisms, signal transduction pathways and potential clinical significances of IL-1β production in LPS and MPA combined treatment, but also to provide experimental data as well as theoretical rationales for more effective and more logical immunosuppressive protocols.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Volunteers,age 18-60.
Key inclusion criteria (1 listed)
- Healthy Volunteers，age 18-60.
Key exclusion criteria (1 listed)
- Don't agree with informed consent
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 |
|---|---|---|
| mycophenolic acidAlso: mycophenolate mofetilMonocytes were co-cultured with LPS and/or MPA.After 12 hours, the supernatants were harvested and stored at -80°C for ELISA. | Drug | – |
Primary outcome
mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes.
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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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.
erwei Sun, doctor study director
Third Affiliated Hospital of Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by The Third Affiliated Hospital of Southern Medical University 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 1 inclusion and 1 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 6 May 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact erwei Sun, doctor (+86 020-62784421, ewsun@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes. (time frame: six 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 6 May 2015.