About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Remote ischemic conditioning
- Sham remote ischemic conditioning
- Standard medication therapy