CClinicalTrials.gg
Sign In
Status unknownNCT04679168Updated Dec 23, 2020

Study on Kidney Disease and EnviromenTal Chemical

An observational study in Covid19, Environmental Exposure and Chronic Kidney Diseases, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-12-23.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
310
Ages
19 Years and older
Sex
All
01

Study summary

  1. Purpose: To confirm the changes in lifestyle due to differences in perceptions of infectious disease risk after the COVID-19 pandemic, decrease in exposure levels of environmentally hazardous chemicals and changes in indicators related to chronic kidney disease

  2. Methods:

    • Survey on health risk awareness and lifestyle for COVID-19
    • Blood and urine tests for exposure to environmentally hazardous chemicals
    • Collection of hospital clinical data utilization for indicators related to chronic kidney disease

  3. Clinical endpoints:

    • Verification of differences in health risk perception level and lifestyle changes
    • Verification of changes in lifestyle changes and exposure to environmentally hazardous chemicals
    • Verification of changes in indicators related to kidney disease according to changes in exposure to environmentally hazardous chemicals
  4. Statistical methods: chi-square test, independent mean comparison t-test, ANOVA test, regression analysis
Read the detailed description
  1. Background In daily life, people are exposed to various environmental hormones (Endocrine Disrupting Chemicals) such as phthalates, bisphenols, heavy metals, and perfluorinated compounds. Due to the recent pandemic of the COVID-19, behavior patterns such as wearing a mask and refraining from going out in daily life have changed. Such behavioral changes have the potential to change the level of exposure to environmental hazards, like intervention studies. In addition, studies have been reported that exposure to various environmental hormones can affect kidney function, but epidemiological studies are insufficient. Therefore, the research team is trying to determine whether exposure to environmental hormones changes due to changes in behavioral patterns according to the new corona epidemic, and to determine the effect on renal function indices in patients with chronic kidney disease.

  2. Hypothesis and Purpose

    • Differences in risk perception for disease after the COVID-19 pandemic can explain the degree of change in lifestyle.
    • The changed lifestyle will lead to reduced exposure to environmentally hazardous substances.
    • Reduction of exposure to environmentally harmful substances will reduce the level of exposure to harmful substances related to kidney disease, which will lead to changes in the prevalence of kidney disease and indicators related to kidney disease.
    • After the COVID-19 pandemic, it is verified whether the exposure level of environmentally hazardous chemicals decreases due to changes in the way of life and differences in perception of the risk of infectious diseases, and confirms which indicators related to chronic kidney disease change accordingly. Identify the role.

  3. Methods (1) During the COVID-19 pandemic

    • Acquisition of consent (using explanations and posters) by explaining the research purpose and method
    • Survey on changes in awareness of diseases and changes in hygiene activities since the COVID-19 pandemic compared to before
    • Measurement of the concentration of environmentally hazardous substances through the acquisition of blood (serum, residual samples after blood tests for treatment) and urine samples that are normally performed in the office (3 months cycle, 4 times)
    • Acquisition of clinical information related to kidney disease (2) Recovery period of the COVID-19 pandemic
    • Survey on changes in awareness of diseases and hygiene activities that have changed since the end of the COVID-19 outbreak
    • Measurement of the concentration of environmentally harmful substances by obtaining blood (serum, residual sample after blood test for medical treatment) and urine sample (once after 6 months of termination)

    • Acquisition of clinical information related to kidney disease (3) Investigation variable

      a) Survey

    • Demographic information
    • Anthropometric information
    • Risk perception for the COVID-19
    • Individual behavior associated with hygiene
    • Social distancing pattern b) Chemical material in human sample (blood, urine)
    • Phthalate metabolite
    • Paraben metabolite
    • Benzophenone
    • Triclosan and triclocarban
    • Bisphenols
    • Phosphate metabolites
    • Organochlorine pesticides
    • Polychlorinated biphenyls c) Clinical information including estimated glomerular filtration rate, urine protein/creatinine ratio
02

Conditions studied

  • Covid19
  • Environmental Exposure
  • Chronic Kidney Diseases

Keywords

  • COVID-19
  • Environmental Exposure
  • Behavioral changes
  • Chronic kidney disease
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 310 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

  • Target number: around 310
  • The total number of participants in the study is around 300-350. In order to figure outcomes, data from the Basic Survey on National Environmental Health were used, and the preceding study (intervention study) was referred to.
  • In multiple regression analysis, the correlation between eGFR and ethylparaben (EtP) was examined by adjusting age, BMI, smoking history, and drinking history. In the full model, where all variables were corrected, R2 was 0.478, and when the independent variable EtP was excluded, R2 decreased by 0.012. Based on these values, as a result of setting the power of 0.7, 0.8, and 0.9 in the multiple regression model, n = 283, 359, and 479, respectively. Based on this result, the number of study participants was set to around 300-350.

Inclusion criteria

  • aged 19 years or older
  • who have been treated twice or more with chronic kidney disease as their main diagnosis in an outpatient department of kidney medicine for more than 3 months

Exclusion criteria

Exclusion Criteria:

  • Patients who do not observe the rapid deterioration of renal function (AKI)
  • Patients who are likely to significantly change their lifestyle and exposure levels of environmentally hazardous chemicals due to the rapid progression of the disease itself, accompanied by the following chronic diseases (malignant tumors, dementia, immunosuppressants Use, stroke within 1 year, cerebral hemorrhage, myocardial infarction)
  • Other patients who have difficulty in general communication or who are unable to carry out their daily life on their own
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
310 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Identification of environmental hazard exposure levels and influencing factors

    * Collecting and organizing survey data * Calculation of technical statistics on exposure to major environmental hazards * Identification of determinants affecting the exposure level of environmentally hazardous substances

    Time frame: From initial recruitment to after 21 (+/- 3) months

  2. Relationship between exposure and health related behavior change

    * Analysis of correlation of kidney disease occurrence according to exposure to harmful substances * Identify the possibility of health effects from exposure to environmentally harmful factors such as disease prevalence, glomerular filtration rate, and urine protein/creatinine ratio according to the definition of chronic kidney disease.

    Time frame: From initial recruitment to after 21 (+/- 3) months

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Boramae Medical Center
    Seoul, 07061, Korea, Republic of
    Recruiting
08

References and documents

Publications

  • Street ME, Angelini S, Bernasconi S, Burgio E, Cassio A, Catellani C, Cirillo F, Deodati A, Fabbrizi E, Fanos V, Gargano G, Grossi E, Iughetti L, Lazzeroni P, Mantovani A, Migliore L, Palanza P, Panzica G, Papini AM, Parmigiani S, Predieri B, Sartori C, Tridenti G, Amarri S. Current Knowledge on Endocrine Disrupting Chemicals (EDCs) from Animal Biology to Humans, from Pregnancy to Adulthood: Highlights from a National Italian Meeting. Int J Mol Sci. 2018 Jun 2;19(6):1647. doi: 10.3390/ijms19061647. PubMed 29865233 ↗
  • Grandjean P, Bellanger M. Calculation of the disease burden associated with environmental chemical exposures: application of toxicological information in health economic estimation. Environ Health. 2017 Dec 5;16(1):123. doi: 10.1186/s12940-017-0340-3. PubMed 29202828 ↗
  • Mascarelli A. Environment: toxic effects. Nature. 2012 Mar 15;483(7389):363-5. doi: 10.1038/nj7389-363a. No abstract available. PubMed 22432121 ↗
  • Watts N, Amann M, Ayeb-Karlsson S, Belesova K, Bouley T, Boykoff M, Byass P, Cai W, Campbell-Lendrum D, Chambers J, Cox PM, Daly M, Dasandi N, Davies M, Depledge M, Depoux A, Dominguez-Salas P, Drummond P, Ekins P, Flahault A, Frumkin H, Georgeson L, Ghanei M, Grace D, Graham H, Grojsman R, Haines A, Hamilton I, Hartinger S, Johnson A, Kelman I, Kiesewetter G, Kniveton D, Liang L, Lott M, Lowe R, Mace G, Odhiambo Sewe M, Maslin M, Mikhaylov S, Milner J, Latifi AM, Moradi-Lakeh M, Morrissey K, Murray K, Neville T, Nilsson M, Oreszczyn T, Owfi F, Pencheon D, Pye S, Rabbaniha M, Robinson E, Rocklov J, Schutte S, Shumake-Guillemot J, Steinbach R, Tabatabaei M, Wheeler N, Wilkinson P, Gong P, Montgomery H, Costello A. The Lancet Countdown on health and climate change: from 25 years of inaction to a global transformation for public health. Lancet. 2018 Feb 10;391(10120):581-630. doi: 10.1016/S0140-6736(17)32464-9. Epub 2017 Oct 30. No abstract available. Erratum In: Lancet. 2018 Feb 10;391(10120):540. doi: 10.1016/S0140-6736(17)33046-5. Lancet. 2020 Jun 6;395(10239):1762. doi: 10.1016/S0140-6736(20)31197-1. PubMed 29096948 ↗
  • Obrador GT, Schultheiss UT, Kretzler M, Langham RG, Nangaku M, Pecoits-Filho R, Pollock C, Rossert J, Correa-Rotter R, Stenvinkel P, Walker R, Yang CW, Fox CS, Kottgen A. Genetic and environmental risk factors for chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):88-106. doi: 10.1016/j.kisu.2017.07.004. Epub 2017 Sep 20. PubMed 30675423 ↗
  • Song JY, Yun JG, Noh JY, Cheong HJ, Kim WJ. Covid-19 in South Korea - Challenges of Subclinical Manifestations. N Engl J Med. 2020 May 7;382(19):1858-1859. doi: 10.1056/NEJMc2001801. Epub 2020 Apr 6. No abstract available. PubMed 32251568 ↗
  • Kang H, Kim S, Lee G, Lee I, Lee JP, Lee J, Park H, Moon HB, Park J, Kim S, Choi G, Choi K. Urinary metabolites of dibutyl phthalate and benzophenone-3 are potential chemical risk factors of chronic kidney function markers among healthy women. Environ Int. 2019 Mar;124:354-360. doi: 10.1016/j.envint.2019.01.028. Epub 2019 Jan 17. PubMed 30660848 ↗
  • Kang H, Lee J, Lee JP, Choi K. Urinary metabolites of organophosphate esters (OPEs) are associated with chronic kidney disease in the general US population, NHANES 2013-2014. Environ Int. 2019 Oct;131:105034. doi: 10.1016/j.envint.2019.105034. Epub 2019 Jul 30. PubMed 31374441 ↗
  • Lee J, Oh S, Kang H, Kim S, Lee G, Li L, Kim CT, An JN, Oh YK, Lim CS, Kim DK, Kim YS, Choi K, Lee JP. Environment-Wide Association Study of CKD. Clin J Am Soc Nephrol. 2020 Jun 8;15(6):766-775. doi: 10.2215/CJN.06780619. Epub 2020 May 22. PubMed 32628126 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04679168
Lead sponsor
Seoul National University Hospital
Responsible party
Jung Pyo Lee (Principal Investigator, M.D., Ph.D., Seoul National University Hospital) — Principal investigator
First posted
Dec 22, 2020
Start date
Jun 1, 2020
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Dec 23, 2020

Study contacts

Jung Pyo Lee, M.D., Ph.D
Contact
nephrolee@gmail.com
+82-2-870-3206
Jeonghwan Lee, Dr.
Contact
woogaelee@naver.com
Jung Pyo Lee, M.D., Ph.D.
principal investigator · SMG-SNU Boramae Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19→

Other studies from this sponsor

Seoul National University Hospital

Start the discussion