NCT03234530|CompletedDMC
World Trade Center Kidney-Link
Linking the Effects of 9/11 to Kidney Disease
Loading search results
Linking the Effects of 9/11 to Kidney Disease
Sponsor study identifier
Secondary identifiers
observational
555
1 country
1
Study Start
November 1, 2017
Actual (reported)Primary Completion
June 1, 2021
Actual (reported)Study Completion
June 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 26, 2017
Actual (reported)July 31, 2017
Actual (reported)November 1, 2017
Actual (reported)June 1, 2021
Actual (reported)June 1, 2021
Actual (reported)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
Berlin questionnaire
day 1
apnea-hypopnea index (AHI)
day 1
WTC Health Program participants
Control group of urban workers in NYC not exposed to the dust from the WTC
World Trade Center rescue and recovery workers and volunteers who are enrolled or being seen in any WTC Clinical Centers of Excellence
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Serum, plasma, urine
Mary Ann McLaughlin, MD, MPH
Icahn School of Medicine at Mount Sinai
555 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2017
First Posted
July 31, 2017
Study Start
November 1, 2017
Actual (reported)Putting Patients at the Center of Kidney Care Transitions (PREPARE NOW)
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2021
Actual (reported)Study Completion
June 1, 2021
Actual (reported)Last Updated
June 9, 2021
Record last verified: 2021-06
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: