Data Standards in Diabetic Kidney Disease

Patient Care Issue

Nearly one-half of patients with kidney diseases, approximately 10 million Americans, have diabetes mellitus. Diabetes accounted for 44% of new cases of kidney failure in 2007. In diabetic kidney disease (also called diabetic nephropathy); cells and blood vessels in the kidneys are damaged, affecting the organs' ability to filter out waste. The progression from initial kidney injury due to diabetes, to diabetic kidney disease, to kidney failure, severely affects patients' quality of life, and is responsible for a very significant morbidity and economic cost for the diabetes and kidney communities.

Challenge

There is a lack of consensus for not only clinical trial endpoints in this area, but also for established standards for clinical research data collection, in order to support the acquisition, exchange, and comparisons of future trials.

Solution

In coordination with the Clinical Data Interchange Standards Consortium (CDISC), Coalition for Accelerating Standards and Therapies (CFAST), FDA, and TransCelerate BioPharma, Inc., KHI assembled a workgroup to help define appropriate standards in the therapeutic area of diabetic kidney disease. KHI's specific role is providing clinical and medical expertise.