World Trade Center Kidney-Link
Linking the Effects of 9/11 to Kidney Disease
2 other identifiers
observational
555
1 country
1
Brief Summary
This study focuses on the prevalence and identification of kidney disease among participants of the WTC Health Program and the study team are planning to assess kidney disease in a multi-factorial manner. The first aim of this study is to correlate kidney dysfunction with 9/11 exposure, and the study team predicts that exposure to 9/11 is an independent risk factor in kidney disease among the WTC Health Program participants. Secondly, the study team proposes that a well-established WTC-related condition, obstructive sleep apnea (OSA), is independently associated with kidney disease. In addition, the study team believe there is a temporal causative relationship between evidence of kidney disease and the severity of OSA. Finally, the last aim is to further identify and explore potential mechanisms and phenotypes of kidney disease in participants of the WTC Health Programs. Regardless of whether the analyses support or reject these hypotheses, the findings will be of equally great public health importance. Successful completion of the proposed research would address a critical knowledge gap regarding the risk of kidney damage among this group of patients, and would inform future mechanistic studies with the potential to impact prevention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
1 active site
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
First Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 31, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJune 9, 2021
June 1, 2021
3.6 years
July 26, 2017
June 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
glomerular filtration rate (eGFR)
eGFR will be calculated using the Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equations. The proposed studies will evaluate differences in the combined creatinine-cystatin C eGFR, which provides the most accurate estimate of GFR, and the creatinine-based CKD-EPI eGFR, which is more practical for use in clinical practice and in monitoring programs. Values \> 200 will be set to 200mL/min/1.73m2
day 1
albuminuria
albumin level in urine
day 1
Secondary Outcomes (2)
Berlin questionnaire
day 1
apnea-hypopnea index (AHI)
day 1
Study Arms (2)
WTC responders
WTC Health Program participants
Urban workers
Control group of urban workers in NYC not exposed to the dust from the WTC
Eligibility Criteria
World Trade Center rescue and recovery workers and volunteers who are enrolled or being seen in any WTC Clinical Centers of Excellence
You may qualify if:
- \- Exposed Group: - Adult patients (35 to 75 years)
- Enrolled or was seen at any of the WTC Clinical Centers of Excellence
- Unexposed Group: - Adult patients (35 to 75 years)
- Lived or worked in NYC at least 10 years since 9/11/01 but were not exposed to the the dust at Ground Zero (not living in proximity of Ground Zero, nor involved in the rescue and recovery at Ground Zero
- Registry Part: - Adult patient (18 to 75 years)
- Enrolled or was seen at any of the WTC Clinical Centers of Excellence or WTC Environmental Health Centers
- With a diagnosis of any Kidney Injury or disease after 9/11/01
You may not qualify if:
- Patients below 18 years of age
- Individuals with an occupation involving chronic exposure to inhaled particulate matter (e.g. iron/steel workers and sand hog workers)
- For the registry part, patients with kidney disease prior to 9/11/01
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Biospecimen
Serum, plasma, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Ann McLaughlin, MD, MPH
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 26, 2017
First Posted
July 31, 2017
Study Start
November 1, 2017
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
June 9, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
The final research data will be a computerized dataset and includes self-reported demographic and medical data, responses from standard questionnaires, as well as results of laboratory tests (urine and blood samples) . Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.