Chronic Kidney DiseasesNCT06963372
Assessment of Health Effects of Air Purifier Interventions on Chronic Kidney Disease Patients
A study of Chronic Kidney Diseases and Particulate Matter, run by Inha University Hospital at 1 site in South Korea.
Trial summary
This exploratory study investigates the impact of indoor air quality improvement via air purifiers on the health of chronic kidney disease (CKD) patients. A randomized, single-blind, crossover study with 24 CKD patients and 24 healthy controls was conducted at two hospitals. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Particulate Matter
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2022to 31 Dec 2022
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Group: Patients aged 20 years or older with stage 3 or higher chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m²).
- Control Group: Individuals aged 20 years or older who have not been told of any kidney function abnormalities based on blood tests within the past year and have never been diagnosed with chronic kidney disease. Baseline labs will be conducted, and only those with an eGFR ≥60 mL/min/1.73 m² will be enrolled. This group includes household members of the patient group or other healthy individuals.
- Individuals who are not currently using a household air purifier.
- Individuals who have consented to participate in the clinical study.
Who cannot join
- Patients with stage 5 chronic kidney disease.
- Individuals with a history of chronic obstructive pulmonary disease (COPD), asthma, allergy, cerebrovascular accident (CVA), malignancy (cancer), cardiovascular interventions, or those with an active infection.
- Individuals taking immunosuppressive medications.
- Patients with diabetes or hypertension whose blood sugar and blood pressure are uncontrolled (HbA1c > 8%, office SBP > 150 mmHg).
Trial locations and contacts
1 site in 1 country.
About this study
This exploratory study investigates the impact of indoor air quality improvement via air purifiers on the health of chronic kidney disease (CKD) patients.
A randomized, single-blind, crossover study with 24 CKD patients and 24 healthy controls was conducted at two hospitals. Participants used either a true filter or a sham filter in air purifiers for four weeks each, with a two-week washout period. True filters significantly reduced indoor PM2.5 levels compared to sham filters. Higher indoor PM2.5 levels were associated with increased cytokines (IL-1beta, IL-6, IL-8/CXCL8) and decreased hemoglobin, with ESR and PWV showing an increasing trend, particularly in CKD patients. True filters significantly reduced IL-1beta and IL-8/CXCL8 levels, with a borderline significant reduction in ABI. The study confirmed limited but notable effects of air purifiers on reducing PM2.5 and improving some health markers in CKD patients.
Read the detailed description
Objectives:
Recent research has demonstrated that increasing levels of fine particulate matter (PM2.5) are associated with reduced glomerular filtration rates and elevated risks of chronic kidney disease (CKD) and end-stage renal disease (ESRD). To mitigate health impacts from PM2.5 exposure, recommendations include limiting outdoor activities, using air purifiers to improve indoor air quality, and wearing protective masks when outdoors. However, scientific evidence on the effectiveness of these interventions remains insufficient, particularly concerning how PM2.5 mitigation affects CKD progression. Therefore, this exploratory study aims to evaluate the impact of indoor air quality improvement via air purifiers on the health of CKD patients.
Methods:
A randomized, single-blind, crossover study was conducted at two university hospitals in Seoul and Incheon, involving 24 CKD patients and 24 healthy controls. Participants underwent two repeated measures with each receiving either a true filter or a sham filter in air purifiers for four weeks, separated by a two-week washout period. The sequence of filter application was counterbalanced between two groups. Data collection included surveys on lifestyle, medical history, and living environment, as well as blood, urine, and vascular endothelial function tests. The relationship between air purifier usage and health outcomes was analyzed.
- Conditions
- Chronic Kidney Diseases, Particulate Matter
- Being tested
- True filter (4w) → Washout (2w) → Sham filter (4w), Sham filter (4w) → Washout (2w) → True filter (4w)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True filter (4w) → Washout (2w) → Sham filter (4w)Device
Used a true filter for 4 weeks, followed by a 2-week washout, then used a sham filter for 4 weeks.
Sham filter (4w) → Washout (2w) → True filter (4w)Device
Used a sham filter for 4 weeks, followed by a 2-week washout, then used a true filter for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A used an air purifier equipped with a true filter for four weeks, followed by a two-week washout period, and then used an air purifier with a sham filter. Receives: Device: True filter (4w) → Washout (2w) → Sham filter (4w) |
| Group B | Experimental | Group B used an air purifier equipped with a sham filter for four weeks, followed by a two-week washout period, and then used an air purifier with a true filter. Receives: Device: Sham filter (4w) → Washout (2w) → True filter (4w) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1beta in pg/mL
Blood samples were collected to analyze cytokines.
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
IL-6 in pg/mL
Blood samples were collected to analyze cytokines.
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
IL-8/CXCL8 in pg/mL
Blood samples were collected to analyze cytokines.
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
IL-10 in pg/mL
Blood samples were collected to analyze cytokines.
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
IFN-gamma in pg/mL
Blood samples were collected to analyze cytokines.
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
TNF-alpha in pg/mL
Blood samples were collected to analyze cytokines.
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Secondary outcomes (4)
Bood pressure (Systolic) in mmHg
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Bood pressure (Diastolic) in mmHg
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Pulse Wave Velocity in m/sec
Pulse Wave Velocity in m/sec
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Ankle-Brachial Pressure Index
Ankle-Brachial Pressure Index (unitless)
Measured: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start11 Apr 2022
- Primary completion1 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, single-blind, crossover study was conducted at two university hospitals in Seoul and Incheon, involving 24 CKD patients and 24 healthy controls. Participants underwent two repeated measures with each receiving either a true filter or a sham filter in air purifiers for four weeks, separated by a two-week washout period. The sequence of filter application was counterbalanced between two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hwan-Cheol Kim, Inha University Hospital
- Investigators
- Hwan-Cheol Kim, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963372
- Sponsor's protocol ID
- 2022-03-023
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Health Effects of Air Purifier Interventions on Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06963372
- Acronym / sponsor ID
- 2022-03-023
- Conditions
- Chronic Kidney Diseases, Particulate Matter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 May 2025 (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.
This exploratory study investigates the impact of indoor air quality improvement via air purifiers on the health of chronic kidney disease (CKD) patients.
A randomized, single-blind, crossover study with 24 CKD patients and 24 healthy controls was conducted at two hospitals. Participants used either a true filter or a sham filter in air purifiers for four weeks each, with a two-week washout period. True filters significantly reduced indoor PM2.5 levels compared to sham filters. Higher indoor PM2.5 levels were associated with increased cytokines (IL-1beta, IL-6, IL-8/CXCL8) and decreased hemoglobin, with ESR and PWV showing an increasing trend, particularly in CKD patients. True filters significantly reduced IL-1beta and IL-8/CXCL8 levels, with a borderline significant reduction in ABI. The study confirmed limited but notable effects of air purifiers on reducing PM2.5 and improving some health markers in CKD patients.
Detailed description
Objectives:
Recent research has demonstrated that increasing levels of fine particulate matter (PM2.5) are associated with reduced glomerular filtration rates and elevated risks of chronic kidney disease (CKD) and end-stage renal disease (ESRD). To mitigate health impacts from PM2.5 exposure, recommendations include limiting outdoor activities, using air purifiers to improve indoor air quality, and wearing protective masks when outdoors. However, scientific evidence on the effectiveness of these interventions remains insufficient, particularly concerning how PM2.5 mitigation affects CKD progression. Therefore, this exploratory study aims to evaluate the impact of indoor air quality improvement via air purifiers on the health of CKD patients.
Methods:
A randomized, single-blind, crossover study was conducted at two university hospitals in Seoul and Incheon, involving 24 CKD patients and 24 healthy controls. Participants underwent two repeated measures with each receiving either a true filter or a sham filter in air purifiers for four weeks, separated by a two-week washout period. The sequence of filter application was counterbalanced between two groups. Data collection included surveys on lifestyle, medical history, and living environment, as well as blood, urine, and vascular endothelial function tests. The relationship between air purifier usage and health outcomes was analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, single-blind, crossover study was conducted at two university hospitals in Seoul and Incheon, involving 24 CKD patients and 24 healthy controls. Participants underwent two repeated measures with each receiving either a true filter or a sham filter in air purifiers for four weeks, separated by a two-week washout period. The sequence of filter application was counterbalanced between two groups.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: True filter (4w) → Washout (2w) → Sham filter (4w)Group A used an air purifier equipped with a true filter for four weeks, followed by a two-week washout period, and then used an air purifier with a sham filter. |
| Group B | Experimental | Device: Sham filter (4w) → Washout (2w) → True filter (4w)Group B used an air purifier equipped with a sham filter for four weeks, followed by a two-week washout period, and then used an air purifier with a true filter. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient Group: Patients aged 20 years or older with stage 3 or higher chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m²).
- Control Group: Individuals aged 20 years or older who have not been told of any kidney function abnormalities based on blood tests within the past year and have never been diagnosed with chronic kidney disease. Baseline labs will be conducted, and only those with an eGFR ≥60 mL/min/1.73 m² will be enrolled. This group includes household members of the patient group or other healthy individuals.
- Individuals who are not currently using a household air purifier.
- Individuals who have consented to participate in the clinical study.
Key exclusion criteria (4 listed)
- Patients with stage 5 chronic kidney disease.
- Individuals with a history of chronic obstructive pulmonary disease (COPD), asthma, allergy, cerebrovascular accident (CVA), malignancy (cancer), cardiovascular interventions, or those with an active infection.
- Individuals taking immunosuppressive medications.
- Patients with diabetes or hypertension whose blood sugar and blood pressure are uncontrolled (HbA1c > 8%, office SBP > 150 mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True filter (4w) → Washout (2w) → Sham filter (4w)Used a true filter for 4 weeks, followed by a 2-week washout, then used a sham filter for 4 weeks. | Device | Group A |
| Sham filter (4w) → Washout (2w) → True filter (4w)Used a sham filter for 4 weeks, followed by a 2-week washout, then used a true filter for 4 weeks. | Device | Group B |
Primary outcome
IL-1beta in pg/mL
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Blood samples were collected to analyze cytokines.
IL-6 in pg/mL
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Blood samples were collected to analyze cytokines.
IL-8/CXCL8 in pg/mL
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Blood samples were collected to analyze cytokines.
IL-10 in pg/mL
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Blood samples were collected to analyze cytokines.
IFN-gamma in pg/mL
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Blood samples were collected to analyze cytokines.
TNF-alpha in pg/mL
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Blood samples were collected to analyze cytokines.
4 secondary outcomes
Bood pressure (Systolic) in mmHg
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Bood pressure (Diastolic) in mmHg
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Pulse Wave Velocity in m/sec
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Ankle-Brachial Pressure Index
Time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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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.
Hwan-Cheol Kim principal investigator
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Kidney Diseases and Particulate Matter, run by Inha 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-1beta in pg/mL (time frame: 0 weeks, 4 weeks, 6 weeks, 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2025.