The Renal Protective Effects of Remote Ischemic Preconditioning in Patients With Chronic Kidney Disease

NCT06501222 | Recruiting

• 1 other identifier: CKDRIC-01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of Chronic kidney disease (CKD) is showing an upward trend, but the therapeutic effect of treatment is limited. Remote ischemic conditioning (RIC) has the potential to safeguard remote organs via the repeated application of brief ischemic stimuli. the aim of our study is to investigate whether RIC can protect the renal function in patients with CKD.

Conditions

Chronic Kidney Diseases

Keywords

remote ischemic conditioning; chronic kidney disease; renal function

Outcome Measures

Primary Outcomes (1)

• change in eGFR

  eGFR is calculated using the CKD-EPI formula, eGFR in mL/min/1.73m²

  3 months and 12 months

Secondary Outcomes (2)

• Changes in renal tissue oxygen saturation (SrtO2) compared to baseline.

  3 months and 12 months

• Changes in blood pressure

  3 months and 12 months

Other Outcomes (3)

• 24-hour urine protein quantitation compared to baseline.

  3 months and 12 months

• change in Pulse Wave Velocity compared to baseline.

  3 months

• change in Flow-mediated vasodilation compared to baseline.

  3 months

Study Arms (2)

RIC group

EXPERIMENTAL

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.

Device: Remote ischemic conditioning

sham-RIC group

SHAM COMPARATOR

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.

Device: Remote ischemic conditioning

Interventions

Remote ischemic conditioning DEVICE

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.

RIC group; sham-RIC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CKD Patients with eGFR ≥ 15ml/min/1.73m2
• Age ≥ 18 years old
• hour urine protein excretion ≤ 3.5g
• Subjects who have signed the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuanjun Yang: lead

Study Sites (1)

chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 32060481 BACKGROUND

• 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.

  PMID: 30115811 BACKGROUND

• 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.

  PMID: 37288603 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangyan Cai

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Yisha Li, PhD

CONTACT

18911772124; xiaoyixueda@qq.com

Dayang Xie, PhD

CONTACT

01055499332; 460436948@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: July 15, 2024
• Study Start: March 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CN (1)