KHI Current Project
Data Standards in Diabetic Kidney Disease
Patient Care Issue:
Nearly one-half of patients with CKD, 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 ERSD severely affects patients’ quality of life, and is responsible for a very significant morbidity and economic cost for the diabetes and kidney
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.
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.
The CDISC Therapeutic Area User Guide for Diabetic Kidney Disease has been published and can be viewed on the CDISC website.
CDISC Therapeutic Area User Guide for Diabetic Kidney Disease (including concept maps, SHARE metadata, SDTM-IG type examples, CDASH annotated CRF examples, and CDASH metadata examples).
Timeframe for Completion:
Richard Haynes, DM, MRCP (Workgroup Co-Chair)
Clinical Trial Service Unit & Epidemiological Studies Unit
University of Oxford
Amy K. Mottl, MD (Workgroup Co-Chair)
Division of Nephrology and Hypertension
UNC School of Medicine
Linda Fried, MD, MPH
VA Pittsburgh Healthcare System
Barbara Ann Greco, MD
Tufts University School of Medicine
Liasion for: Collaborative Study Group
Andrew Narva, MD
Division of Kidney, Urologic, and Hematologic Disease, NIDDK
Meda E. Pavkov, MD, PhD (KHI Board of Directors)
Centers for Disease Control
Marlon Pragnell, PhD
John R. Sedor, MD, FASN
Case Western Reserve University
Liaison for: American Society of Nephrology
Shoba Sharma, MS
Kimberly Smith, MD, MS
Center for Drug Evaluation and Research, FDA
Katherine Tuttle, MD, FASN (KHI Board of Directors)
Providence Health Care
Jula Inrig, MD, MHS, FASN (KHI Board of Directors)
Quintiles Global Clinical Research Organization
Conflict of Interest:
To view KHI's Conflict of Interest and Disclosure Policy please click here.