ACTRN12626000963325进行中(未招募)不适用
An open-label pilot clinical investigation to evaluate the safety, performance, and clinical feasibility of photobiomodulation (PBM) in Adults with Chronic Kidney Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 No limit(—)
- 性别
- All
入选标准
- •Ages over 18 Years
- •CKD with estimated glomerular filtration rate (eGFR) 30-89 ml/min/173m
- •Urine albumin creatinine ration (UACR) is between 30 mg/mmol and 500 mg/mmol.
- •Stable standard of care concomitant medication for 3 months
- •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.
- •All eligible patients will be receiving a sodium-glucose cotransporter-2 (SGLT2) inhibitor unless contraindicated.
- •The inclusion of the patients on a mineralocorticoid receptor antagonist such as finerenone will be at the discretion of the investigators.
排除标准
- •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.
- •Patients on renal replacement therapy or kidney transplant.
- •Patients with acute clinical events (Recent hospitalization during last 3 months).
- •Severe liver disease (ALT and/or AST):> 3x ULN, Direct bilirubin:> 3 x ULN.
- •History or presence of any form of cancer within the three years prior to enrolment.
- •Symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
- •Pregnant or breast-feeding woman.
- •Patients with active malignancy.
研究者
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