The Renal Protective Effects of Remote Ischemic Preconditioning in Patients With Chronic Kidney Disease
The Renal Protective Effects of Remote Ischemic Preconditioning in Patients With Chronic Kidney Disease: Randomized, Parallel-controlled, proof-of Concept Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic kidney disease (CKD) is characterized by progressive and irreversible loss of nephrons. Currently, due to the increasing prevalence of diabetes, hypertension, obesity, and the impact of population aging, the incidence of CKD is showing an upward trend. The treatment of CKD is mostly aimed at delaying the progression of renal function, but the therapeutic effect is limited, causing a continuous economic burden for CKD patients. Therefore, there is an urgent need to develop new treatment methods to prevent or reverse the progression of the disease.
Remote ischemic conditioning (RIC) is a process that involves repeatedly applying brief ischemic stimuli to a certain organ or tissue, which stimulates the body's endogenous anti-ischemic injury ability, enabling other organs or tissues besides the stimulated one to adapt to ischemia and improve their tolerance to ischemic injury, thereby reducing the damage caused by ischemia to relevant organs or tissues. Current studies have confirmed that RIC can protect remote organs such as the heart, brain, and kidneys through multiple pathways, including humoral mechanisms, neural conduction regulation mechanisms, and immune inflammatory regulation mechanisms. However, current research in the field of kidney diseases has been mostly limited to acute kidney injury caused by contrast agents, surgery, etc., and there are no reports on the intervention and treatment of CKD patients using RIC. Therefore, exploring whether RIC can delay the progression of renal function in CKD patients is of great significance.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yisha Li, PhD
- Phone Number: 18911772124
- Email: xiaoyixueda@qq.com
Study Contact Backup
- Name: Dayang Xie, PhD
- Phone Number: 01055499332
- Email: 460436948@qq.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Yisha Li, PhD
- Phone Number: 18911772124
- Email: xiaoyixueda@qq.com
-
Contact:
- Dayang Xie, PhD
- Phone Number: 01055499332
- Email: 460436948@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- CKD Patients with eGFR ≥ 15ml/min/1.73m2
- Age ≥ 18 years old
- 24-hour urine protein excretion ≤ 3.5g
- Subjects who have signed the informed consent form
Exclusion Criteria:
- Patients with nephrotic syndrome
- Patients with acute kidney injury
- Patients who have undergone renal replacement treatment in the past
- Patients who may have medication changes during RIC or sham-RIC intervention
- Patients with a history of diabetes or glycated hemoglobin > 8%
- Patients with familial hypercholesterolemia (>5.5 mmol/L) accompanied by high low-density lipoprotein (>2.5 mmol/L)
- Patients with contraindications to RIC, such as vascular injury, soft tissue injury, fracture, infection, or known peripheral vascular disease in both arms
- Patients with a history of hemostatic disorders, systemic bleeding, or thrombocytopenia
- 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)
- Uncontrolled hypertension (defined as systolic blood pressure ≥ 200 mmHg despite antihypertensive treatment)
- Patients with respiratory failure, malignant tumors, or other autoimmune diseases
- Women who are pregnant or breastfeeding at the time of enrollment or any time during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RIC group
The RIC protocol involves five cycles of alternating inflation of both upper arms, utilizing an automated device to alternately inflate to 200 mmHg for 5 minutes and deflate for 5 minutes.
|
RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm.
RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
|
|
Sham Comparator: sham-RIC group
The sham-RIC protocol involves five cycles of alternating inflation of both upper arms, utilizing an automated device to alternately inflate to 60 mmHg for 5 minutes and deflate for 5 minutes.
|
RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm.
RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in eGFR
Time Frame: 3 months and 12 months
|
eGFR is calculated using the CKD-EPI formula, eGFR in mL/min/1.73m²
|
3 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in renal tissue oxygen saturation (SrtO2) compared to baseline.
Time Frame: 3 months and 12 months
|
SrtO2 is measured by Near Infrared Spectroscopy
|
3 months and 12 months
|
|
Changes in blood pressure
Time Frame: 3 months and 12 months
|
blood pressure in mmHg
|
3 months and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-hour urine protein quantitation compared to baseline.
Time Frame: 3 months and 12 months
|
The 24-hour urine protein quantitation is monitored through urine.
|
3 months and 12 months
|
|
change in Pulse Wave Velocity compared to baseline.
Time Frame: 3 months
|
brachial-ankle Pulse Wave Velocity in cm/s
|
3 months
|
|
change in Flow-mediated vasodilation compared to baseline.
Time Frame: 3 months
|
FMD in %
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Guangyan Cai, Chinese PLA General Hospital
Publications and helpful links
General Publications
- Ruiz-Ortega M, Rayego-Mateos S, Lamas S, Ortiz A, Rodrigues-Diez RR. Targeting the progression of chronic kidney disease. Nat Rev Nephrol. 2020 May;16(5):269-288. doi: 10.1038/s41581-019-0248-y. Epub 2020 Feb 14.
- Zhou D, Ding J, Ya J, Pan L, Wang Y, Ji X, Meng R. Remote ischemic conditioning: a promising therapeutic intervention for multi-organ protection. Aging (Albany NY). 2018 Aug 16;10(8):1825-1855. doi: 10.18632/aging.101527.
- Zhang YN, Dai YJ, Cui Y, Wu Q, Zhang NN, Chen HS. Diabetes, fasting blood glucose and the efficacy of remote ischaemic conditioning: A secondary analysis of the RICAMIS trial. Diabetes Obes Metab. 2023 Sep;25(9):2689-2696. doi: 10.1111/dom.15156. Epub 2023 Jun 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKDRIC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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