Protecting kidney function using remote ischemic conditioning in chronic kidney disease patients

The Renal Protective Effects of Remote Ischemic Preconditioning in Patients With Chronic Kidney Disease: Randomized, Parallel-controlled, proof-of Concept Trial

This study is testing if a new method called remote ischemic conditioning can help protect kidney function in people with chronic kidney disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06501222 on ClinicalTrials.gov

What this trial studies

This study investigates the potential of remote ischemic conditioning (RIC) to protect renal function in patients with chronic kidney disease (CKD). CKD is characterized by the progressive loss of kidney function, and current treatments primarily focus on slowing its progression. RIC involves applying brief ischemic stimuli to stimulate the body's protective mechanisms, potentially improving kidney resilience to injury. The study aims to explore whether RIC can delay the deterioration of kidney function in CKD patients, addressing a significant unmet need in their management.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with CKD and an eGFR of 15 ml/min/1.73m² or higher.

Not a fit: Patients with acute kidney injury, nephrotic syndrome, or those requiring renal replacement therapy are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel method to preserve kidney function and improve quality of life for CKD patients.

How similar studies have performed: While RIC has shown promise in protecting other organs, its application in CKD is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. CKD Patients with eGFR ≥ 15ml/min/1.73m2
2. Age ≥ 18 years old
3. 24-hour urine protein excretion ≤ 3.5g
4. Subjects who have signed the informed consent form

Exclusion Criteria:

1. Patients with nephrotic syndrome
2. Patients with acute kidney injury
3. Patients who have undergone renal replacement treatment in the past
4. Patients who may have medication changes during RIC or sham-RIC intervention
5. Patients with a history of diabetes or glycated hemoglobin \> 8%
6. Patients with familial hypercholesterolemia (\>5.5 mmol/L) accompanied by high low-density lipoprotein (\>2.5 mmol/L)
7. Patients with contraindications to RIC, such as vascular injury, soft tissue injury, fracture, infection, or known peripheral vascular disease in both arms
8. Patients with a history of hemostatic disorders, systemic bleeding, or thrombocytopenia
9. Patients with cardiogenic embolism (atrial fibrillation) or other severe arrhythmias (severe bradycardia, third-degree atrioventricular block, or ventricular tachycardia), previous myocardial infarction, or severe heart failure (New York Heart Association Class III and IV)
10. Uncontrolled hypertension (defined as systolic blood pressure ≥ 200 mmHg despite antihypertensive treatment)
11. Patients with respiratory failure, malignant tumors, or other autoimmune diseases
12. Women who are pregnant or breastfeeding at the time of enrollment or any time during the study

Where this trial is running

Beijing, Beijing Municipality

• chinese PLA general hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yisha Li, PhD

Conditions Chronic Kidney Diseases; remote ischemic conditioning; chronic kidney disease; renal function