Kidney Health Initiative Project Explores Cardiovascular Clinical Trials for People with Kidney Diseases


Kidney disease is common in people with cardiovascular disease (1, 2), and managing cardiovascular disease in people with kidney diseases is an important clinical problem. However, the evidence to support optimal management is hampered by the continual exclusion of people with kidney diseases from cardiovascular trials (14). In order to understand this problem and determine potential solutions, a Kidney Health Initiative (KHI) project aims to identify the barriers to involving people with kidney diseases—with a focus on those with advanced chronic kidney disease (stage 4) and end stage renal disease—in cardiovascular trials and strategies to overcome these challenges.

Achieving these aims requires input from a variety of stakeholders, including patients, academia, industry, academic and contract research organizations, and regulators. This is being accomplished through diverse representation on the workgroup, online surveys designed to elicit perspectives on barriers and solutions, and a workshop that will review the challenges and identify actionable strategies to address them. The results of the project will be detailed in a future white paper targeted for completion in late 2018.

Please visit the KHI website for more details about the project or to complete the online survey:

April 2018 (Vol. 10, Number 4)


1. Coca SG, et al. Underrepresentation of renal disease in randomized controlled trials of cardiovascular disease. J Am Med Assoc 2006; 296:1377–1384.

2. Charytan D, Kuntz RE. The exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease. Kidney Int 2006; 70:2021–2030.

3. Konstantinidis I, et al. Representation of patients with kidney disease in trials of cardiovascular interventions: An updated systematic review. JAMA Intern Med 2016; 176:121–124.

4. Ishida JH, Johansen KL. Exclusion of patients with kidney disease from cardiovascular trials. JAMA Intern Med 2016; 176:124–125.