Lupus Nephritis: Role of Environmental and Occupational Exposures
Primary Purpose
Lupus Nephritis
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Lupus Nephritis focused on measuring Case-Control, Hydrocarbons, Metals, Silica, Tobacco Smoke, Lupus Nephritis, Environmental Exposures, Occupational Exposures
Eligibility Criteria
INCLUSION CRITERIA: Have renal biopsy proven Lupus Nephritis (with the biopsy-based diagnosis date no earlier than January 1, 1995). Reside within designated counties of eastern North Carolina and South Carolina.
Sites / Locations
- University of North Carolina
- NIEHS, Research Triangle Park
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00342329
First Posted
June 19, 2006
Last Updated
June 30, 2017
Sponsor
National Institute of Environmental Health Sciences (NIEHS)
1. Study Identification
Unique Protocol Identification Number
NCT00342329
Brief Title
Lupus Nephritis: Role of Environmental and Occupational Exposures
Official Title
Lupus Nephritis: Role of Environmental and Occupational Exposures
Study Type
Observational
2. Study Status
Record Verification Date
March 7, 2007
Overall Recruitment Status
Completed
Study Start Date
April 16, 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 7, 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Environmental Health Sciences (NIEHS)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to examine hormonal and environmental risk factors (and possible gene-environmental interactions) involved in the etiology of lupus nephritis. Our study will focus on exposures to occupational and environmental agents that have been linked to the development of systemic lupus erythematosus (SLE) or renal disease (e.g., silica dust, smoking). We will also assess potential gene environment interactions. We will examine these exposures in 100 patients with renal biopsy with documented proliferative or membraneous nephritis. We will compare exposures in the lupus nephritis patients to lupus patients who do not have nephritis and to normal controls who have participated in the Carolina Lupus Study. One hundred lupus nephritis patients (age 18 years or older, of both genders and all races) will be identified through the Glomerular Disease Collaborative Network (GDCN) Nephropathology database and participating nephrologists at the Medical University of South Carolina, Duke University Medical Center and the East Carolina Medical School.
Detailed Description
The purpose of this study is to examine hormonal and environmental risk factors (and possible gene-environmental interactions) involved in the etiology of lupus nephritis. Our study will focus on exposures to occupational and environmental agents that have been linked to the development of systemic lupus erythematosus (SLE) or renal disease (e.g., silica dust, smoking). We will also assess potential gene environment interactions. We will examine these exposures in 100 patients with renal biopsy with documented proliferative or membraneous nephritis. We will compare exposures in the lupus nephritis patients to lupus patients who do not have nephritis and to normal controls who have participated in the Carolina Lupus Study. One hundred lupus nephritis patients (age 18 years or older, of both genders and all races) will be identified through the Glomerular Disease Collaborative Network (GDCN) Nephropathology database and participating nephrologists at the Medical University of South Carolina, Duke University Medical Center and the East Carolina Medical School.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Case-Control, Hydrocarbons, Metals, Silica, Tobacco Smoke, Lupus Nephritis, Environmental Exposures, Occupational Exposures
7. Study Design
Enrollment
0 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Have renal biopsy proven Lupus Nephritis (with the biopsy-based diagnosis date no earlier than January 1, 1995).
Reside within designated counties of eastern North Carolina and South Carolina.
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7030
Country
United States
Facility Name
NIEHS, Research Triangle Park
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States
12. IPD Sharing Statement
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Lupus Nephritis: Role of Environmental and Occupational Exposures
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