Remote Ischemic Conditioning for the Treatment of Diabetic Kidney Disease

NCT06654921 | Not Yet Recruiting DMC

• 1 other identifier: RIC-DKD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic kidney disease (CKD) is a growing epidemic affecting 10% of the population worldwide. Significantly, diabetic kidney disease (DKD) is the main cause of CKD and affects approximately 40% of patients with diabetes. Approximately 10% of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive. Moreover, DKD progresses particularly rapidly and has a poor prognosis, accounting for almost 50% of end-stage renal disease (ESRD) cases. Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs. Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings . In the renal setting, RIP performed in dialysis patients is known to abrogate brain, heart and liver ischemia occurring during hemodialysis treatments. RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury. However, whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study. Our overarching hypothesis is that RIP, performed in DKD patients, could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney. The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD.

Conditions

Diabetic Kidney Disease (DKD)

Outcome Measures

Primary Outcomes (1)

• The tolerability of RIC in patients with DKD

  Patients who complete at least of twice a day up to 5 months of RIC treatment are considered to be tolerable of RIC.

  0-6 months

Secondary Outcomes (12)

• ΔSerum creatinine

  0-6 months

• ΔSerum Cystatin C

  0-6 months

• ΔHemoglobin

  0-6 months

• ΔSerum KIM-1

  0-6 months

• ΔUrine microalbumin-creatinine ratio

  0-6 months

Study Arms (2)

RIC group

EXPERIMENTAL

Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment.

Device: Remote ischemic conditioning; Drug: Standard medication therapy

Sham group

SHAM COMPARATOR

Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment.

Device: Sham remote ischemic conditioning; Drug: Standard medication therapy

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 procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment.

Also known as: RIC

RIC group

Sham remote ischemic conditioning DEVICE

Sham RIC will be performed by the same electric auto-control device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (60 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment.

Also known as: Sham RIC

Sham group

Standard medication therapy DRUG

Standard medication therapy will be performed according to the national and international guidelines.

RIC group; Sham group

Eligibility Criteria

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

You may qualify if:

• History of type 2 diabetes and receiving at least 1 antidiabetic medication
• CKD at stage G3 or G4 (eGFR = 15-60 mL/min/1.73 m2)
• UACR ≥ 300 mg/g or urinary albumin excretion rate (UAER) ≥ 300 mg/24 h
• Patients are cognitively and physically capable and willing to interact with the device and perform self-measurements
• Ability to withstand 5 full minutes of cuff inflation during prescreening

You may not qualify if:

• Patients with New York Heart Association Class III or IV congestive heart failure at enrollment
• Patients with severe illness with an expected lifespan of less than 6 months
• Patients with a recent history (\< 6 months) of continuous renal replacement therapy, malignant tumor, myocardial infarction, acute coronary syndrome, stroke, seizure, thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism), or a cerebrovascular accident
• Patients with known severe arterial disease of the extremities (ulcers, amputations, known symptomatic peripheral arterial disease)
• Patients at imminent risk of starting dialysis during the study period
• Patients residing in a long-term care facility
• Patients in another interventional trial that could influence the intervention or outcome of this trial

Sponsors & Collaborators

• Capital Medical University: lead

Related Publications (7)

• Bello AK, Levin A, Tonelli M, Okpechi IG, Feehally J, Harris D, Jindal K, Salako BL, Rateb A, Osman MA, Qarni B, Saad S, Lunney M, Wiebe N, Ye F, Johnson DW. Assessment of Global Kidney Health Care Status. JAMA. 2017 May 9;317(18):1864-1881. doi: 10.1001/jama.2017.4046.

  PMID: 28430830 BACKGROUND

• Wakashima T, Tanaka T, Fukui K, Komoda Y, Shinozaki Y, Kobayashi H, Matsuo A, Nangaku M. JTZ-951, an HIF prolyl hydroxylase inhibitor, suppresses renal interstitial fibroblast transformation and expression of fibrosis-related factors. Am J Physiol Renal Physiol. 2020 Jan 1;318(1):F14-F24. doi: 10.1152/ajprenal.00323.2019. Epub 2019 Oct 21.

  PMID: 31630548 BACKGROUND

• Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.

  PMID: 29042490 BACKGROUND

• Ekeloef S, Homilius M, Stilling M, Ekeloef P, Koyuncu S, Munster AB, Meyhoff CS, Gundel O, Holst-Knudsen J, Mathiesen O, Gogenur I. The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): phase II randomised clinical trial. BMJ. 2019 Dec 4;367:l6395. doi: 10.1136/bmj.l6395.

  PMID: 31801725 BACKGROUND

• Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.

  PMID: 26024502 BACKGROUND

• Li H, Satriano J, Thomas JL, Miyamoto S, Sharma K, Pastor-Soler NM, Hallows KR, Singh P. Interactions between HIF-1alpha and AMPK in the regulation of cellular hypoxia adaptation in chronic kidney disease. Am J Physiol Renal Physiol. 2015 Sep 1;309(5):F414-28. doi: 10.1152/ajprenal.00463.2014. Epub 2015 Jul 1.

  PMID: 26136559 BACKGROUND

• Wang L, Jia L, Huang S, Ren C, Yu Y, Wang Y, Zhao W, Ji X, Li S. Safety and efficacy of remote ischaemic preconditioning in diabetic kidney disease: a pilot randomised, parallel-arm, sham-controlled trial protocol. BMJ Open. 2025 Sep 3;15(9):e096851. doi: 10.1136/bmjopen-2024-096851.

  PMID: 40903083 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Xunming Ji, MD, PhD

CONTACT

010-83199430; jixm@ccmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: October 23, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share