None listed
Conditions
Brief summary
This study aims to evaluate the safety and feasibility of PBM, a non-invasive light therapy, in adults with chronic kidney disease. PBM has shown potential to reduce inflammation and improve cellular function, but its use in people with chronic kidney disease has not been well studied. Participants will receive PBM treatment twice weekly for 24 weeks and will be followed for a further 24 weeks. The study will assess whether PBM can be delivered safely and whether participants can successfully complete the treatment program.
Interventions
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
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).
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed