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The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and LPS on IL-1β Secretion by Mononuclear

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ClinicalTrials.gov Identifier: NCT02435368
Recruitment Status : Unknown
Verified April 2015 by Xuechan Huang, The Third Affiliated Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Xuechan Huang, The Third Affiliated Hospital of Southern Medical University

Tracking Information
First Submitted Date April 25, 2015
First Posted Date May 6, 2015
Last Update Posted Date May 6, 2015
Study Start Date April 2015
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2015)
mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes. [ Time Frame: six months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and LPS on IL-1β Secretion by Mononuclear
Official Title The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and Lipopolysaccharide on Interleukin-1β Secretion by Mononuclear
Brief Summary 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Peripheral blood was obtained from healthy donors,mononuclear cells (PBMCs) were isolated using Ficoll density gradient centrifugation, and LPS (1 μg/ml) and/or MPA were added. After 12 hours, the supernatants were harvested and stored at -80°C for ELISA.
Sampling Method Non-Probability Sample
Study Population Healthy Volunteers,age 18-60.
Condition Lupus Nephritis
Intervention Drug: mycophenolic acid
Monocytes were co-cultured with LPS and/or MPA.After 12 hours, the supernatants were harvested and stored at -80°C for ELISA.
Other Name: mycophenolate mofetil
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 30, 2015)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2016
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Healthy Volunteers,age 18-60.

Exclusion Criteria:

  • Don't agree with informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02435368
Other Study ID Numbers 201501001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Xuechan Huang, The Third Affiliated Hospital of Southern Medical University
Study Sponsor The Third Affiliated Hospital of Southern Medical University
Collaborators Not Provided
Investigators
Study Director: erwei Sun, doctor Third Affiliated Hospital of Southern Medical University
PRS Account The Third Affiliated Hospital of Southern Medical University
Verification Date April 2015