Clinical research in the end stage renal disease (ESRD) patient population is uniquely challenging. ESRD patients are medically complex, perhaps more so than any other patient population. Such medical complexity arises from the disease sequelae of renal impairment progressing to kidney failure, as well as the disease burden of other medical conditions that commonly burden these patients.

Studies have shown an increased prevalence of coronary artery disease, cancer, peripheral arterial disease and obstructive pulmonary disease in ESRD patients. Many ESRD patients also have diabetes and, as a result, frequently have impaired vision due to diabetic retinopathy. They also often have peripheral neuropathy. Older patients can also have moderate to severe chronic cognitive impairment.

Although not necessarily the direct result of ESRD, other conditions often seen in this patient population include agitation, delirium, anemia, anorexia, dyspnea, fatigue, pain, nausea, pruritus, sexual dysfunction and sleep disturbance. Additional stressors associated with ESRD include biochemical imbalance, physiological changes and neurological disturbances. Dermatologic manifestations associated with renal disease are also not uncommon.

Beyond these various comorbid and adjacent disease conditions, one must also simply consider the life of an ESRD patient, especially hemodialysis (HD) patients: travel logistics for HD treatments three times a week, a substantial pill burden, obtaining regular access to care, dietary concerns and more. The list goes on.

Finally, when thinking about enrollment rates, one must consider that incident dialysis patients are not only more challenging to identify than prevalent dialysis patients, they are more challenging to recruit simply because they have so much else (becoming an ESRD patient) going on in their lives to deal with. This is another consideration that may be important to factor into the protocol.

Such a medically complex patient population creates certain challenges when designing a clinical trial for success. In this case, I define “success” as a study that achieves its enrollment and completion timelines. Successful clinical trials in the ESRD patient population are designed with the patient in mind from the very start. I’ve seen sponsors learn this the hard way after wasting valuable time and money because they had underestimated the complex medical nature of the ESRD population.

In my next blog, I will discuss why the system of care that delivers dialysis therapy cannot be ignored when designing and conducting a successful clinical trial in the ESRD patient population.


About the Author

Kurt Mussina, MBA
Vice President, General Manager

Kurt Mussina brings more than 25 years of international business success to his role at Frenova, including a record of leadership and achievement structuring and orchestrating global business development teams in the CRO industry. As vice president, general manager, he is responsible for building organizational alignment of functions to drive profits and research success. Before joining Frenova, Mussina held a number of executive positions, including as president of Triangle Research Labs; senior vice president of business development for Aptiv Solutions and Nuvilex; vice president of business development and client services for Aptuit; and vice president for global clinical business development for Inveresk, among others. Mussina earned a Bachelor of Science in chemistry from Montclair State University and received his MBA from Duke University, Fuqua School of Business.