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Updated: Jul 1, 2025
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Assessment of Vascular Function in Patients With Chronic Kidney Disease
Published on: June 16, 2014
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Representation of Patients With Chronic Kidney Disease in Clinical Trials of Cardiovascular Disease Medications: A
Julia M T Colombijn1,2, Demy L Idema3, Sanne van Beem1
1Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, the Netherlands.
JAMA Network Open
|March 7, 2024
Summary
Patients with chronic kidney disease (CKD) are underrepresented in cardiovascular trials, with exclusion rates increasing. This leads to significant evidence gaps for cardiovascular risk management medications in CKD populations.
Area of Science:
- Cardiovascular Medicine
- Nephrology
- Clinical Trials Methodology
Background:
- Patients with chronic kidney disease (CKD) face a high risk of cardiovascular disease (CVD).
- Underrepresentation of CKD patients in cardiovascular randomized clinical trials (RCTs) hinders evidence generation for effective cardiovascular risk management (CVRM).
Approach:
- A systematic search of ClinicalTrials.gov and other databases identified 1194 cardiovascular RCTs published from 2000 to 2021.
- RCTs evaluating CVRM medications in adults with CVD or risk factors were included, excluding trials with fewer than 100 participants.
Key Points:
- Exclusion of CKD patients from cardiovascular RCTs increased from 66% to 79% since 2000.
- Most RCTs (72%) excluded more CKD patients than anticipated, often citing safety concerns.
- Only 13% of RCTs reported separate results for CKD patients, with minimal data for advanced CKD stages (e.g., GFR < 30 mL/min/1.73 m2).
Conclusions:
- CKD patient representation in cardiovascular RCTs has not improved over two decades.
- Exclusion and underreporting of results create significant evidence gaps for CVRM medications across all CKD stages, especially advanced stages.
- Further research is crucial to guide CVRM in the underrepresented CKD population.
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