NCT02435368

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

April 25, 2015

Last Update Submit

April 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes.

    six months

Interventions

Monocytes were co-cultured with LPS and/or MPA.After 12 hours, the supernatants were harvested and stored at -80°C for ELISA.

Also known as: mycophenolate mofetil

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Volunteers,age 18-60.

You may qualify if:

  • Healthy Volunteers,age 18-60.

You may not qualify if:

  • Don't agree with informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510630, China

RECRUITING

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.

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • erwei Sun, doctor

    Third Affiliated Hospital of Southern Medical University

    STUDY DIRECTOR

Central Study Contacts

erwei Sun, doctor

CONTACT

xuechan Huang, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Xuechan Huang

Study Record Dates

First Submitted

April 25, 2015

First Posted

May 6, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

March 1, 2016

Last Updated

May 6, 2015

Record last verified: 2015-04

Locations