Chronic Kidney Disease: How A Deeper Understanding of the Disease Is Impacting Clinical Development

Now known to be an independent risk factor for numerous adverse health outcomes – especially cardiovascular disease (CVD) – chronic kidney disease (CKD) is a global public health issue. Over time, the emergence of a classification system historically allowed for the improved identification and risk stratification of CKD, and with it came a better understanding of its related implications to comorbid disease and mortality.

While this deeper understanding of the disease has led to a number of opportune areas of study for clinical trials, there are numerous challenges ahead from the discovery of the underlying disease processes to the identification and recruitment of the target population. Furthermore, although the prevalence, health burden and mortality of comorbid disease is much higher in the CKD population, most trials exclude patients with renal impairment. As such, clinicians have a more limited picture of how to manage such patients.

Join Medpace’s medical and clinical operations experts as they discuss important topics including:

Medical perspective:

• An overview of CKD and its related comorbid conditions including CVD and the impact on clinical development
• Important tests related to the evaluation of CKD
• Potential areas of study in relation to these disease processes
• Study design considerations
• Future opportunities [e.g., biomarkers for prediction]

Operational perspective:

• Feasibility approaches
• Optimizing patient recruitment and retention [IntelliPACE®]
• Lessons-learned from related clinical trials

Speakers

Ajay Srivastava, MD, FASN, Sr. Medical Director, Medical Department, Medpace

Dr. Ajay Srivastava is a board-certified nephrologist with an extensive background in both clinical and academic medicine. Specializing in adult nephrology, he brings over 13 years of experience in both the common and rare conditions of the kidney, renal replacement therapies, ICU nephrology including IV fluid resuscitation and management, and comorbid conditions such as cardiorenal syndrome and hypertension. As an interventional nephrologist, he also provided education, assistance, and evaluation regarding matters of dialysis vascular access including the performance of interventional procedures to preserve, optimize, and salvage these hemodialysis accesses. Dr. Srivastava has also held several other leadership positions including Director of Nephrology Fellowship Training, the Medical Directorship of dialysis facilities, Division Chief of Nephrology, and Interim Chair of Medicine, and has served on a number of departmental, hospital, and university committees.

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Carrie Sheil, Sr. Director, Clinical Trial Management, Medpace

Ms. Sheil has more than 16 years of experience in clinical research including clinical monitoring and global trial management of Phase 1-4 studies, and programs with DOD and non-diluted funding. Ms. Sheil has experience in a wide array of indications and therapeutic areas including but not limited to Nephrology, Rare Disease, Metabolic, Cardiovascular as well as Infectious Disease. Ms. Sheil’s leadership is reflected in successful execution of quality, efficient, consistent results across multiple studies and programs.

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