Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000963325
Ethics application status
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Approved
Date submitted
Help: Date submitted
14/07/2026
Date registered
Help: Date registered
6/08/2026
Date last updated
Help: Date last updated
7/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A pilot study to assess the safety and feasibility of photobiomodulation (light therapy) for adults with chronic kidney disease
Scientific title
An open-label pilot clinical investigation to evaluate the safety, performance, and clinical feasibility of photobiomodulation (PBM) in Adults with Chronic Kidney Disease
Additional trial identifiers [1] 317896 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
chronic kidney disease 342846 0
Condition category
Condition code
Renal and Urogenital 338959 338959 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will receive photobiomodulation (PBM) therapy, a non-invasive light therapy, using a PBM device. Each participant will be allocated sequentially (alternating), as they enroll in the study, to one of two treatment groups:
Arm1: Kidney-targeted PBM group, PBM treatment applied to 10 points over the back in the kidney region.

All participants will receive active PBM treatment and there is no placebo or sham treatment group. The PBM device is applied transcutaneously using a handheld probe placed in direct contact with the skin at pre-specified anatomical points for a fixed duration per point according to study protocol.

PBM therapy will be delivered face-to-face on by a trained study operator at the study site. Participants will receive PBM therapy intervention twice weekly for 24 weeks (a total of 48 PBM treatment sessions). Each session will last approximately 30 minutes, including pre-treatment wellbeing and positioning checks, approximately 20 minutes of PBM treatment, and a brief post-treatment observation period to monitor for any immediate effects.

Treatment adherence will be monitored using attendance records, with completed sessions recorded against the planned schedule and missed sessions documented. All study operators will receive training (2–4 hours face-to-face) by an experienced PBM therapist prior to study commencement (at least 2–3 weeks before first enrolment).
Intervention code [1] 334744 0
Treatment: Devices
Description of the comparator or control
Arm2: Abdomen-targeted PBM group, PBM treatment applied to 9 points around the abdominal region and 1 point at the C1/C2 region of the neck.
Control group
Active

Outcomes
Primary outcome [1] 346200 0
Safety of transcutaneous PBM targeted to the kidney or abdominal region in adults with chronic kidney disease
Timepoint [1] 346200 0
Continuously monitored from baseline to Week 48, with formal assessments at Week 12, Week 24 (end of treatment), and Week 48 (end of follow-up).
Primary outcome [2] 346201 0
Recruitment feasibility of transcutaneous PBM targeted to the kidney or abdominal region in adults with chronic kidney disease.
Timepoint [2] 346201 0
Recruitment rate will be assessed at the end of the recruitment period.
Primary outcome [3] 346314 0
Treatment adherence of transcutaneous PBM targeted to the kidney or abdominal region in adults with chronic kidney disease.
Timepoint [3] 346314 0
Treatment adherence will be assessed at the end of treatment period (Week 24).
Secondary outcome [1] 464964 0
Percentage of participant with >=30% reduction in urinary albumin-to-creatinine ratio (UACR).
Timepoint [1] 464964 0
Baseline, Week 12, Week 24 (end of treatment), and Week 48 (end of follow-up).
Secondary outcome [2] 464965 0
Change in estimated glomerular filtration rate (eGFR).
Timepoint [2] 464965 0
Baseline, Week 12, Week 24 (end of treatment), and Week 48 (end of follow-up).
Secondary outcome [3] 464966 0
Change in serum creatinine concentration.
Timepoint [3] 464966 0
Baseline, Week 12, Week 24 (end of treatment), and Week 48 (end of follow-up).
Secondary outcome [4] 464967 0
Change in health-related quality of life.
Timepoint [4] 464967 0
Baseline, Week 12, Week 24 (end of treatment), and Week 48 (end of follow-up).
Secondary outcome [5] 464968 0
Change in whole blood cell counts.
Timepoint [5] 464968 0
Baseline, Week 12, Week 24 (end of treatment), and Week 48 (end of follow-up).
Secondary outcome [6] 464969 0
Exploratory outcomes include changes in cytokines biomarkers (i.e. TGF-ß, TNF-a, MCP-1, IL-6).
Timepoint [6] 464969 0
Baseline, Week 12, and Week 24 (end of treatment).
Secondary outcome [7] 464971 0
Change in gut microbiota composition.
Timepoint [7] 464971 0
Baseline, Week 12, and Week 24 (end of treatment).
Secondary outcome [8] 465386 0
Study completion and retention rate (Primary outcome).
Timepoint [8] 465386 0
Treatment completion rate will be assessed at the end of the treatment period (Week 24). Retention rate will be assessed at the end of the study period (Week 48).
Secondary outcome [9] 465429 0
Exploratory outcomes include changes in antioxidant levels (i.e. glutathione peroxidase-1).
Timepoint [9] 465429 0
Baseline, Week 12, and Week 24 (end of treatment).
Secondary outcome [10] 465430 0
Change in gut microbiota-related metabolites, including the kynurenine-to-tryptophan ratio.
Timepoint [10] 465430 0
Baseline, Week 12, and Week 24 (end of treatment).

Eligibility
Key inclusion criteria
1. Ages over 18 Years
2. CKD with estimated glomerular filtration rate (eGFR) 30-89 ml/min/173m2.
3. Urine albumin creatinine ration (UACR) is between 30 mg/mmol and 500 mg/mmol.
4. Stable standard of care concomitant medication for 3 months
5. All eligible patients will be on a stable, maximum to dose of an Angiotensin-Converting Enzyme (ACE) or Angiotensin II Receptor Blocker (ARB) for 2 weeks prior to study enrolment. Note: The determination of m tolerated ACE or ARB therapy will be at the discretion of the site principal investigators.
6. All eligible patients will be receiving a sodium-glucose cotransporter-2 (SGLT2) inhibitor unless contraindicated.
7. The inclusion of the patients on a mineralocorticoid receptor antagonist such as finerenone will be at the discretion of the investigators.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Any serious medical condition or psychiatric illness that, in the opinion of the treating physician, impairs the individual’s ability to provide valid informed consent, or any condition, including clinically significant laboratory abnormalities, that places the individual at unacceptable risk if they were to participate in the study or may confound the interpretation of study data.
2. Patients on renal replacement therapy or kidney transplant.
3. Patients with acute clinical events (Recent hospitalization during last 3 months).
4. Severe liver disease (ALT and/or AST):> 3x ULN, Direct bilirubin:> 3 x ULN.
5. History or presence of any form of cancer within the three years prior to enrolment.
6. Symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
7. Pregnant or breast-feeding woman.
8. Patients with active malignancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322435 0
Other
Name [1] 322435 0
Renal Research Lab, Kolling Institute
Country [1] 322435 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 325360 0
None
Name [1] 325360 0
Address [1] 325360 0
Country [1] 325360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320928 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 320928 0
Ethics committee country [1] 320928 0
Australia
Date submitted for ethics approval [1] 320928 0
02/06/2026
Approval date [1] 320928 0
10/08/2026
Ethics approval number [1] 320928 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152106 0
Prof Carol Pollock
Address 152106 0
Level 7 Kolling Building, Kolling Institute, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 152106 0
Australia
Phone 152106 0
+61 2 99264652
Fax 152106 0
Email 152106 0
[email protected]
Contact person for public queries
Name 152107 0
Chunling Huang
Address 152107 0
Level 9 Kolling Building, Kolling Institute, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 152107 0
Australia
Phone 152107 0
+61 2 99264784
Fax 152107 0
Email 152107 0
[email protected]
Contact person for scientific queries
Name 152108 0
Chunling Huang
Address 152108 0
Level 9 Kolling Building, Kolling Institute, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 152108 0
Australia
Phone 152108 0
+61 2 99264784
Fax 152108 0
Email 152108 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be shared due to the small sample size and the potential risk of participant re-identification. Only aggregated study results will be reported in presentations or publications in accordance with ethical and regulatory requirement.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.