Chronic Kidney Disease(CKD)Laser_CKDNCT06855992
Transcutaneous Laser Therapy in Chronic Kidney Disease
A study testing Laser and Red Light in people with Chronic Kidney Disease(CKD), run by National Cheng-Kung University Hospital.
Trial summary
Chronic kidney disease (CKD) affects approximately 10% of the global population, totaling over 800 million people. In Taiwan, one in eight individuals is diagnosed with CKD. According to National Health Insurance data, acute kidney injury and CKD rank first in medical expenditures, imposing a significant burden on… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease(CKD)
- What is being tested?
- Laser and Red Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged >20 years diagnosed with chronic kidney disease (CKD) stages 2-5.
- Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m² (lasting for more than three months).
- Willing to provide routine blood test results before, during, and after each phase of the study.
Who cannot join
- Acute kidney changes within the past three months (e.g., >30% decline in eGFR), or individuals with impaired consciousness, shortness of breath, or inability to follow instructions.
- Blood pressure exceeding 160 mmHg at the time of participation.
- Severe cardiovascular diseases (e.g., pacemaker implantation), upper limb trauma or infections, systemic lupus erythematosus, or skin cancer.
- Use of photosensitizing medications, pregnancy, or malignant tumors.
- Sensory nerve abnormalities, coagulation disorders, or the presence of kidney stones.
- Individuals with a hierarchical relationship to the study's principal investigator or team members (e.g., those from the same laboratory or having a student-mentor relationship).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of Transcutaneous Laser Therapy in Chronic Kidney Disease
Chronic kidney disease (CKD) affects approximately 10% of the global population, totaling over 800 million people. In Taiwan, one in eight individuals is diagnosed with CKD. According to National Health Insurance data, acute kidney injury and CKD rank first in medical expenditures, imposing a significant burden on patients' quality of life and the national healthcare system. Early intervention in CKD, especially for high-risk populations (e.g., individuals with diabetes or early-stage kidney dysfunction), can slow disease progression, delay the onset of kidney failure, and postpone the need for dialysis.
Transcutaneous venous laser therapy is a non-invasive treatment. Current literature has demonstrated that it enhances blood circulation, alters blood and erythrocyte activity, and exhibits immunomodulatory, anti-inflammatory, and vasodilatory effects on the blood. Additionally, it boosts mitochondrial activity, which is crucial as mitochondria act as the energy powerhouses of cells, providing the necessary energy for kidneys to maintain normal function.
This project aims to investigate whether this non-invasive transcutaneous venous laser therapy can reduce inflammation, improve physical activity, and further enhance patients' quality of life. It also seeks to reduce patients' medical expenses and National Health Insurance costs.
- Conditions
- Chronic Kidney Disease(CKD)
- Being tested
- Laser, Red Light
- Keywords
- chronic kidney disease
- 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.
LaserDevice
60-minute 635 nm red laser intervention 3 times per week for 8 weeks
Red LightDevice
60-minute red light sham intervention three times per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Laser first then sham | Other | Administer a 60-minute, 635 nm laser intervention three times per week for 8 weeks, followed by a 6-week washout period. Subsequently, provide a 60-minute red light sham intervention three times per week for another 8 weeks. Receives: Device: Laser; Device: Red Light |
| Sham first then laser | Other | Administer a 60-minute red light sham intervention three times per week for 8 weeks, followed by a 6-week washout period. Subsequently, provide a 60-minute, 635 nm laser intervention three times per week for another 8 weeks. Receives: Device: Laser; Device: Red Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basic data
Participant demographic data and relevant medical histories will be collected, including gender, age, medication usage, chronic diseases, major illnesses, and surgical history.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Weight
The participant's body weight is measured in kilograms (kg) using a calibrated digital. The measurement is taken with the participant standing upright, wearing light clothing and no shoes to ensure accuracy.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Height
The participant's height is measured in centimeters (cm) using a stadiometer or a height-measuring rod. The measurement is taken with the participant standing upright, feet together, heels against the wall or stadiometer, and head in the Frankfort horizontal plane. The participant should be barefoot and maintain a natural posture.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Body Mass Index
Body Mass Index (BMI) is measured by first recording the participant's weight in kilograms (kg) using a calibrated scale while they are barefoot and wearing light clothing. Height is then measured in meters (m) using a stadiometer, with the participant standing upright, feet together. BMI is calculated using the formula BMI = weight (kg) / height (m)².
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Blood pressure and heart rate
Blood pressure and heart rate are measured with the participant seated comfortably in a quiet environment for at least 5 minutes. A calibrated automatic sphygmomanometer is used to measure systolic and diastolic blood pressure (mmHg) on the upper arm, with the cuff positioned at heart level. Heart rate (beats per minute) is recorded using the same device.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Blood parameters
Blood parameters, including blood urea nitrogen (BUN), serum creatinine, glomerular filtration rate (GFR), nitrogen, sodium, potassium, phosphorus, hemoglobin, and pH levels, will be measured through venous blood samples collected under standardized conditions.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Handgrip strength
Maximal grip strength was assessed using a calibrated dynamometer while the participant stood with feet shoulder-width apart and arms relaxed at their sides. The test was conducted three times using the dominant hand, and the highest value from the three trials was recorded for analysis.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Knee extensor strength
The knee extensor strength will be assessed using a hand-held dynamometer to ensure accurate and reliable measurements. Participants will be positioned in a standardized manner, typically seated with their knees at a 90-degree flexion to maintain consistency across trials. The dynamometer will be placed just above the ankle, and participants will be instructed to exert maximal isometric contraction against the device. Each measurement will be performed three times, with brief rest periods between trials to minimize fatigue.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Sit-to-stand test
The Sit-to-Stand Test is a functional assessment used to evaluate lower limb strength, endurance, and balance. During the test, the participant sits in a standardized chair with feet flat on the floor and arms crossed over the chest, then repeatedly stands up and sits down as many times as possible within 30 seconds. The total number of completed repetitions is recorded, with a higher count indicating better functional endurance.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
2-minute step test
For the 2-Minute Step Test, participants were instructed to step in place at a comfortable pace for two minutes, ensuring that the knee was raised to a height midway between the iliac crest and the patella with each step. The total number of times the right knee reached the specified height during the test period was recorded for analysis.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
MIP assesses inspiratory muscle strength. The participant sits upright with a nose clip and exhales fully to residual volume (RV) before performing a maximal inspiratory effort against a closed valve. The highest pressure (cmH₂O) from 3 trials is recorded.
MEP evaluates expiratory muscle strength. The participant sits upright with a nose clip, inhales fully to total lung capacity (TLC), and performs a forceful maximal expiration against a closed valve. The highest pressure (cmH₂O) from 3 trials is recorded.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
The Kidney Disease Quality of Life-36 (KDQOL-36)
The Kidney Disease Quality of Life-36 (KDQOL-36) scale is a measure of health-related quality of life (HRQoL) in individuals with kidney disease, with scores ranging from 0 to 100, where higher scores indicate better HRQoL. The KDQOL-36 consists of five subscales: the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS), where higher scores reflect better physical and mental health, respectively; the Effects of Kidney Disease on Daily Life subscale, where higher scores signify less impact on daily activities; the Burden of Kidney Disease subscale, where higher scores represent a lower perceived burden of the disease; and the Symptoms and Problems of Kidney Disease subscale, where higher scores indicate fewer symptoms and problems.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Time up and go test
The participant sits on a standard-height chair, stands up without using their hands (unless necessary), walks 3 meters (10 feet) to a designated marker, turns around, walks back to the chair, and sits down, with timing starting upon standing and stopping once seated.
Measured: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start17 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by National Cheng-Kung 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Feng Lin, National Cheng-Kung University Hospital
- Investigators
- Cheng-Feng Lin Professor, PhD, Principal investigator, National Cheng-Kung University HospitalChien-Yao Sun MD, Principal investigator, National Cheng-Kung University HospitalWei-Hung Lin MD, Principal investigator, National Cheng-Kung University HospitalLi-Chieh Kuo Professor, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855992
- Sponsor's protocol ID
- B-BR-113-066-T
- Acronym
- Laser_CKD
- Status last verified
- Jan 2025
- First submitted
- 21 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Laser Therapy in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06855992
- Acronym / sponsor ID
- Laser_CKD / B-BR-113-066-T
- Conditions
- Chronic Kidney Disease(CKD)
- Keywords
- chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 4 Mar 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.
Chronic kidney disease (CKD) affects approximately 10% of the global population, totaling over 800 million people. In Taiwan, one in eight individuals is diagnosed with CKD. According to National Health Insurance data, acute kidney injury and CKD rank first in medical expenditures, imposing a significant burden on patients' quality of life and the national healthcare system. Early intervention in CKD, especially for high-risk populations (e.g., individuals with diabetes or early-stage kidney dysfunction), can slow disease progression, delay the onset of kidney failure, and postpone the need for dialysis.
Transcutaneous venous laser therapy is a non-invasive treatment. Current literature has demonstrated that it enhances blood circulation, alters blood and erythrocyte activity, and exhibits immunomodulatory, anti-inflammatory, and vasodilatory effects on the blood. Additionally, it boosts mitochondrial activity, which is crucial as mitochondria act as the energy powerhouses of cells, providing the necessary energy for kidneys to maintain normal function.
This project aims to investigate whether this non-invasive transcutaneous venous laser therapy can reduce inflammation, improve physical activity, and further enhance patients' quality of life. It also seeks to reduce patients' medical expenses and National Health Insurance costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser first then sham | Other | Device: Laser, Device: Red LightAdminister a 60-minute, 635 nm laser intervention three times per week for 8 weeks, followed by a 6-week washout period. Subsequently, provide a 60-minute red light sham intervention three times per week for another 8 weeks. |
| Sham first then laser | Other | Device: Laser, Device: Red LightAdminister a 60-minute red light sham intervention three times per week for 8 weeks, followed by a 6-week washout period. Subsequently, provide a 60-minute, 635 nm laser intervention three times per week for another 8 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged >20 years diagnosed with chronic kidney disease (CKD) stages 2-5.
- Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m² (lasting for more than three months).
- Willing to provide routine blood test results before, during, and after each phase of the study.
Key exclusion criteria (6 listed)
- Acute kidney changes within the past three months (e.g., >30% decline in eGFR), or individuals with impaired consciousness, shortness of breath, or inability to follow instructions.
- Blood pressure exceeding 160 mmHg at the time of participation.
- Severe cardiovascular diseases (e.g., pacemaker implantation), upper limb trauma or infections, systemic lupus erythematosus, or skin cancer.
- Use of photosensitizing medications, pregnancy, or malignant tumors.
- Sensory nerve abnormalities, coagulation disorders, or the presence of kidney stones.
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 |
|---|---|---|
| Laser60-minute 635 nm red laser intervention 3 times per week for 8 weeks | Device | Laser first then sham, Sham first then laser |
| Red Light60-minute red light sham intervention three times per week for 8 weeks | Device | Laser first then sham, Sham first then laser |
Primary outcome
Basic data
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Participant demographic data and relevant medical histories will be collected, including gender, age, medication usage, chronic diseases, major illnesses, and surgical history.
Weight
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
The participant's body weight is measured in kilograms (kg) using a calibrated digital. The measurement is taken with the participant standing upright, wearing light clothing and no shoes to ensure accuracy.
Height
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
The participant's height is measured in centimeters (cm) using a stadiometer or a height-measuring rod. The measurement is taken with the participant standing upright, feet together, heels against the wall or stadiometer, and head in the Frankfort horizontal plane. The participant should be barefoot and maintain a natural posture.
Body Mass Index
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Body Mass Index (BMI) is measured by first recording the participant's weight in kilograms (kg) using a calibrated scale while they are barefoot and wearing light clothing. Height is then measured in meters (m) using a stadiometer, with the participant standing upright, feet together. BMI is calculated using the formula BMI = weight (kg) / height (m)².
Blood pressure and heart rate
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Blood pressure and heart rate are measured with the participant seated comfortably in a quiet environment for at least 5 minutes. A calibrated automatic sphygmomanometer is used to measure systolic and diastolic blood pressure (mmHg) on the upper arm, with the cuff positioned at heart level. Heart rate (beats per minute) is recorded using the same device.
Blood parameters
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Blood parameters, including blood urea nitrogen (BUN), serum creatinine, glomerular filtration rate (GFR), nitrogen, sodium, potassium, phosphorus, hemoglobin, and pH levels, will be measured through venous blood samples collected under standardized conditions.
Handgrip strength
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Maximal grip strength was assessed using a calibrated dynamometer while the participant stood with feet shoulder-width apart and arms relaxed at their sides. The test was conducted three times using the dominant hand, and the highest value from the three trials was recorded for analysis.
Knee extensor strength
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
The knee extensor strength will be assessed using a hand-held dynamometer to ensure accurate and reliable measurements. Participants will be positioned in a standardized manner, typically seated with their knees at a 90-degree flexion to maintain consistency across trials. The dynamometer will be placed just above the ankle, and participants will be instructed to exert maximal isometric contraction against the device. Each measurement will be performed three times, with brief rest periods between trials to minimize fatigue.
Sit-to-stand test
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
The Sit-to-Stand Test is a functional assessment used to evaluate lower limb strength, endurance, and balance. During the test, the participant sits in a standardized chair with feet flat on the floor and arms crossed over the chest, then repeatedly stands up and sits down as many times as possible within 30 seconds. The total number of completed repetitions is recorded, with a higher count indicating better functional endurance.
2-minute step test
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
For the 2-Minute Step Test, participants were instructed to step in place at a comfortable pace for two minutes, ensuring that the knee was raised to a height midway between the iliac crest and the patella with each step. The total number of times the right knee reached the specified height during the test period was recorded for analysis.
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
MIP assesses inspiratory muscle strength. The participant sits upright with a nose clip and exhales fully to residual volume (RV) before performing a maximal inspiratory effort against a closed valve. The highest pressure (cmH₂O) from 3 trials is recorded. MEP evaluates expiratory muscle strength. The participant sits upright with a nose clip, inhales fully to total lung capacity (TLC), and performs a forceful maximal expiration against a closed valve. The highest pressure (cmH₂O) from 3 trials is recorded.
The Kidney Disease Quality of Life-36 (KDQOL-36)
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
The Kidney Disease Quality of Life-36 (KDQOL-36) scale is a measure of health-related quality of life (HRQoL) in individuals with kidney disease, with scores ranging from 0 to 100, where higher scores indicate better HRQoL. The KDQOL-36 consists of five subscales: the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS), where higher scores reflect better physical and mental health, respectively; the Effects of Kidney Disease on Daily Life subscale, where higher scores signify less impact on daily activities; the Burden of Kidney Disease subscale, where higher scores represent a lower perceived burden of the disease; and the Symptoms and Problems of Kidney Disease subscale, where higher scores indicate fewer symptoms and problems.
Time up and go test
Time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
The participant sits on a standard-height chair, stands up without using their hands (unless necessary), walks 3 meters (10 feet) to a designated marker, turns around, walks back to the chair, and sits down, with timing starting upon standing and stopping once seated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Cheng-Feng Lin Professor, PhD principal investigator
National Cheng-Kung University Hospital
Chien-Yao Sun MD principal investigator
National Cheng-Kung University Hospital
Wei-Hung Lin MD principal investigator
National Cheng-Kung University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Laser and Red Light in people with Chronic Kidney Disease(CKD), run by National Cheng-Kung University Hospital.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng Feng Lin, PhD (+886-6-2353535 ext. 5721, connie@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basic data (time frame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks). The study lists 13 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 18 Mar 2025.