Chronic kidney disease is a serious, slowly progressing condition, culminating in end-stage renal disease. Developers of treatments for this condition face a range of challenges in the clinical development process. Ensuring timely, quality, cost-effective execution of ESRD clinical trials requires a research organization to leverage the right people, processes, and technology infrastructure to overcome the trial complexities inherent in ESRD drug development. This white paper explores the complexities of running clinical trials in advanced CKD and the ESRD populations and looks at the solutions that can be employed to overcome challenges.