Research in the CKD clinic: highs and lows.

Despite rates of CKD continuing to increase, the current evidence base used to guide CKD management is smaller than that for many other chronic diseases. Clinical investigators face multiple barriers to conducting research in patients with CKD. CKD patients have multiple comorbidities that make them a risky intervention target; thus, they are often excluded from trials. The lack of approved surrogate endpoints for kidney disease progression makes testing therapies to slow progression very challenging and expensive. Patients with CKD have higher rates of disability and lower educational status than the general population, which further complicates their participation in clinical trials. Despite these barriers, it is imperative that scientific progress be made in this patient population. Increasing education and information regarding CKD clinical trials through brochures and public awareness campaigns may increase trial participation. The U.S. Food and Drug Administration needs to approve the new definition of glomerular filtration rate decline because this will result in a decrease in the cost of clinical trials and make industry more likely to invest in trials in patients with CKD. Successful research in this patient population is possible, but it requires collaboration among investigators, health-care providers, patients, industry, and the National Institutes of Health.