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Trial record 13 of 1164 for:    MYCOPHENOLIC ACID

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

Brief Summary:
To determine the mechanisms and significances of synergistic effects of mycophenolic acid and LPS on IL-1β secretion by mononuclear

Condition or disease Intervention/treatment
Lupus Nephritis Drug: mycophenolic acid

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.


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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and Lipopolysaccharide on Interleukin-1β Secretion by Mononuclear
Study Start Date : April 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : March 2016



Intervention Details:
  • 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


Primary Outcome Measures :
  1. mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes. [ Time Frame: six months ]

Biospecimen Retention:   Samples Without DNA
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.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Volunteers,age 18-60.
Criteria

Inclusion Criteria:

  • Healthy Volunteers,age 18-60.

Exclusion Criteria:

  • Don't agree with informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435368


Contacts
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Contact: erwei Sun, doctor +86 020-62784421 ewsun@263.net
Contact: xuechan Huang, doctor +86 15521116926 flycicada@163.com

Locations
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China, Guangdong
Third Affiliated Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: erwei Sun, doctor    +86 020-62784421    ewsun@263.net   
Contact: xuechan Huang, doctor    +86 15521116926    flycicada@163.com   
Sponsors and Collaborators
The Third Affiliated Hospital of Southern Medical University
Investigators
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Study Director: erwei Sun, doctor Third Affiliated Hospital of Southern Medical University

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Responsible Party: Xuechan Huang, Dr.Xuechan Huang, The Third Affiliated Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02435368     History of Changes
Other Study ID Numbers: 201501001
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Mycophenolic Acid
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action