Covid19NCT04679168
Study on Kidney Disease and EnviromenTal Chemical
An observational study of Covid19 and Environmental Exposure, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Covid19, Environmental Exposure, Chronic Kidney Diseases
- How many people
- 310 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2020to 31 Dec 2021
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jeonghwan Lee, Dr. contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Boramae Medical Center
Seoul, 07061
Jeonghwan Lee, Prof., 82-2-870-3243, woogaelee@naver.com
Yaerim Kim, Prof., 82-53-258-7745, yaerim86@gmail.com
About this study
Official title: Change of Environmental Chemical Exposures and Prevalence of Chronic Kidney Disease After Epidemiological Spread of SARS-CoV-2 (COVID-19)
- 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
- 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
Read more
- 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
- Statistical methods: chi-square test, independent mean comparison t-test, ANOVA test, regression analysis
Read the detailed description
- 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.
- 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.
- 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
- 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
- Conditions
- Covid19, Environmental Exposure, Chronic Kidney Diseases
- Keywords
- COVID-19, Environmental Exposure, Behavioral changes, Chronic kidney disease
- Medical subject headings
- COVID-19, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From initial recruitment to after 21 (+/- 3) months
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.
Measured: From initial recruitment to after 21 (+/- 3) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Pyo Lee, Seoul National University Hospital
- Investigators
- Jung Pyo Lee, M.D., Ph.D., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679168
- Sponsor's protocol ID
- SKETCH
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 29865233Grandjean 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 29202828Mascarelli A. Environment: toxic effects. Nature. 2012 Mar 15;483(7389):363-5. doi: 10.1038/nj7389-363a. No abstract available.
PubMed 22432121Watts 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.
PubMed 29096948Obrador 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 30675423Song 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 32251568Kang 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 30660848Kang 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 31374441Lee 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 32628126Kang MW, Kim Y, Lee I, Park H, Park JY, An JN, Yoo KD, Kim YC, Park NY, Kho Y, Choi K, Lee JP, Lee J. Longitudinal behavioral changes and factors related to reinforced risk aversion behavior among patients with chronic kidney disease during the COVID-19 pandemic. Sci Rep. 2022 Sep 22;12(1):15780. doi: 10.1038/s41598-022-19787-0.
PubMed 36138060
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Environmental Chemical Exposures and Prevalence of Chronic Kidney Disease After Epidemiological Spread of SARS-CoV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04679168
- Acronym / sponsor ID
- SKETCH
- Conditions
- Covid19, Environmental Exposure, Chronic Kidney Diseases
- Keywords
- COVID-19, Environmental Exposure, Behavioral changes, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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
- 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
- Statistical methods: chi-square test, independent mean comparison t-test, ANOVA test, regression analysis
Detailed description
- 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.
- 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.
- 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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of environmental hazard exposure levels and influencing factors
Time frame: From initial recruitment to after 21 (+/- 3) months
* 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
Relationship between exposure and health related behavior change
Time frame: From initial recruitment to after 21 (+/- 3) months
* 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 29865233Street 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.
- Background: PubMed 29202828Grandjean 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.
- Background: PubMed 22432121Mascarelli A. Environment: toxic effects. Nature. 2012 Mar 15;483(7389):363-5. doi: 10.1038/nj7389-363a. No abstract available.
- Background: PubMed 29096948Watts 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.
- Background: PubMed 30675423Obrador 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.
- Background: PubMed 32251568Song 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.
- Results publication: PubMed 30660848Kang 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.
- Results publication: PubMed 31374441Kang 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.
- Results publication: PubMed 32628126Lee 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.
- Derived from this study: PubMed 36138060Kang MW, Kim Y, Lee I, Park H, Park JY, An JN, Yoo KD, Kim YC, Park NY, Kho Y, Choi K, Lee JP, Lee J. Longitudinal behavioral changes and factors related to reinforced risk aversion behavior among patients with chronic kidney disease during the COVID-19 pandemic. Sci Rep. 2022 Sep 22;12(1):15780. doi: 10.1038/s41598-022-19787-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeonghwan Lee, Dr. contact
Jung Pyo Lee, M.D., Ph.D. principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Environmental Exposure, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Pyo Lee, M.D., Ph.D (+82-2-870-3206, nephrolee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of environmental hazard exposure levels and influencing factors (time frame: From initial recruitment to after 21 (+/- 3) months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679168, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.