March is National Kidney Month, an annual event dedicated to raising awareness about kidney disease. Chronic kidney disease, or CKD, describes a condition in which the kidneys are damaged and cannot filter blood as they should and resulting in a loss of kidney function over time. Very common, it affects approximately one in seven adults in the United States, with nearly 200,000 people being diagnosed each year. More concerning, many people who have CKD aren’t even aware they have it. The condition can progress to end-stage kidney failure, which is fatal without dialysis or a kidney transplant.
Treatments for chronic kidney disease focus on slowing the progression of the organ damage. The number of randomized clinical trials in kidney disease lags behind other conditions like cancer, heart disease and immunology. However, there is a growing demand given the current incidence of the disease and coupled with an aging population and an increasing prevalence of risk factors such as diabetes, obesity and high blood pressure.
In addition to the growing prevalence of kidney disease, the connection to several comorbidities is a key consideration for clinical research. For example, there is a strong association between CKD and cardiovascular disease. Therefore, many cardiovascular treatments are prescribed to individuals who also have kidney disease. However, renal patients are often excluded from safety and efficacy testing for such therapies. There may be a variety of contributing factors, but frequently, research teams are concerned about extraneous factors and adverse events. At the same time, there may also be a variety of social and physical barriers inhibiting renal patients from participating.
As discussed in a previous blog, diversity and inclusion in clinical trials is critical. It is uniquely important for conditions like CKD, where there are several comorbidities and conditions that are risk factors. In November 2020, the U.S. FDA published their most recent guidance on the topic: Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs. The guidance suggests ways to expand clinical trial eligibility criteria with inclusive trial practice and designs to better reflect the populations who will ultimately use the therapy under investigation. In addition, its section on trial design and methodological approaches includes guidance encouraging sponsors to characterize metabolism and clearance in key subpopulations early.
“Consider characterizing — in early clinical development — drug metabolism and clearance across populations that may metabolize or clear the drug differently (e.g., across the elderly and patients with liver or kidney dysfunction). Early characterization of drug metabolism and clearance across groups will help avoid later exclusions. Alternatively, an expansion cohort may also allow dose modification and may be used to assess a reasonably safe dose in specific populations in which there may be significant differences in the systemic exposure to the investigational drug (e.g., pediatric or elderly participants or participants with organ impairment).”
Cardiologists and nephrologists are also committed to driving inclusion of patients with kidney disease in cardiovascular trials through efforts of the Kidney Health Initiative. The project brings together public and private stakeholders to understand the barriers in including patients with kidney disease in cardiovascular trials and identify potential strategies to overcome them.
Mednet’s platform is well-suited to support the need to increase diversity in trials, while also enabling a variety of study types, designs and therapeutic categories. Its flexible platform and validated study replication tools allow customers to get their nephrology studies up and running quickly. The requirement for greater diversity and inclusion in clinical research demands an innovative mindset, openness to new approaches, and operational flexibility. Mednet’s flexible platform supports like mid-trial modifications that may need to be made for things like expanding participants, while helping research teams respond quickly and efficiently. This level of flexibility also enables adaptive design trials and positions sponsor teams to develop new operating procedures that meet the requirements and demands of the moment. At the same time, Mednet’s novel ePRO capabilities also render on any browser. This essential functionality broadens access for trial participants through a wide range of devices. These are two small examples of how the Mednet product strategy aligns with the emerging needs of the market and specific therapeutic categories.
Technology can significantly streamline processes and improve efficiency in all studies, but particularly in studies with unique study designs or considerations. Given the breadth of capabilities and the overall flexibility of the platform, along with the team’s extensive experience running studies across all therapeutic categories, Mednet is well-positioned to enable research teams to build and conduct their nephrology studies and/or related conditions with ease. To learn more about Mednet’s flexible platform or our therapeutic expertise, contact us.