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Updated: Nov 16, 2025
Assessment of Vascular Function in Patients With Chronic Kidney Disease
Published on: June 16, 2014
Management of Cardiovascular Disease in Kidney Disease Study: Rationale and Design
Ashutosh M Shukla1,2, Mark S Segal3,4, Carl J Pepine5
1Department of Medicine, North Florida/South Georgia Veterans Health System, Gainesville, Florida, USA, ashutosh.shukla@medicine.ufl.edu.
Insights
Low-dose hydroxychloroquine may reduce cardiovascular disease risk in chronic kidney disease (CKD) patients by targeting inflammation and vascular stiffness. This study investigates its potential benefits for atherosclerosis and cardiovascular mortality in CKD.
Area of Science:
- Nephrology
- Cardiology
- Pharmacology
Background:
- Cardiovascular disease (CVD) is a leading cause of mortality in chronic kidney disease (CKD) patients, with conventional treatments showing limited efficacy.
- Atherosclerosis, inflammation, and vascular stiffness are key interrelated risk factors for CVD in CKD.
- Low-dose hydroxychloroquine has demonstrated anti-inflammatory and vascular protective effects in preclinical and rheumatologic studies.
Purpose of the Study:
- To evaluate the efficacy of low-dose hydroxychloroquine in mitigating atherosclerosis, inflammation, and vascular stiffness in patients with CKD.
- To test the hypothesis that hydroxychloroquine offers significant cardiovascular benefits in the CKD population.
- To provide proof-of-applicability for hydroxychloroquine as a novel therapy for CVD in CKD.
Main Methods:
- A phase 2B, randomized, double-blind, placebo-controlled trial (NCT03636152) involving 100 high-risk CKD patients.
- Treatment with low-dose hydroxychloroquine or placebo for 18 months.
- Assessment of changes in carotid plaque volume, inflammation markers, vascular stiffness, and renal function.
Main Results:
- Primary outcome: Change in total carotid plaque volume via serial noncontrast carotid MRI.
- Secondary outcomes: Serial changes in plasma inflammation markers, vascular stiffness, renal function, and carotid plaque composition.
- The study aims to establish the impact of hydroxychloroquine on key CVD parameters in CKD.
Conclusions:
- This trial will determine the potential of hydroxychloroquine for treating cardiovascular disease in CKD patients.
- Positive results could support larger phase-3 trials investigating clinical endpoints.
- Hydroxychloroquine represents a potentially transformative, inexpensive therapeutic option for CVD in CKD.
Introduction:
Atherosclerosis, inflammation, and vascular stiffness are prominent interrelated risk factors contributing to the high incidence of cardiovascular disease (CVD) in patients with CKD. Conventional CVD management strategies in CKD largely target atherosclerotic CVD and have had a limited impact on the cardiovascular mortality in this population. Multiple in vivo and in vitro studies and epidemiological evidence from the rheumatologic cohorts have shown that low-dose hydroxychloroquine has beneficial effects on inflammation, endothelial function, insulin sensitivity, and metabolic syndrome. Our recent proof-of-concept animal study showed that hydroxychloroquine has marked protection against atherosclerosis and vascular stiffness. We hypothesize that hydroxychloroquine has the potential to provide significant cardiovascular benefits in patients with CKD.
Methods:
The Management of Cardiovascular disease in Kidney disease study (NCT03636152) is a phase 2B, randomized, double-blind, placebo-controlled trial evaluating the effects of low-dose hydroxychloroquine therapy on the parameters of atherosclerosis, inflammation, and vascular stiffness in patients with CKD. The study plans to enroll 100 CKD patients estimated to be at high cardiovascular risk by a combination of low estimated glomerular filtration rate and albuminuria and treat them for 18 months with hydroxychloroquine or placebo in 1:1 allocation.
Results:
The study will assess the change in the total carotid plaque volume as measured by serial noncontrast carotid MRI as the primary outcome and the serial changes in plasma inflammation markers, vascular stiffness, renal function, and the composition characteristics of the carotid plaque as secondary outcome measures.
Discussion/Conclusion:
The results of this trial will provide the proof-of-applicability for hydroxychloroquine in the CVD in CKD. If positive, this trial should lead to phase-3 trials with clinical end points for this potentially transformative, novel, and inexpensive therapy for CVD in CKD.
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