Kidney Health Initiative (KHI)

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 communities.


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.

KHI 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.


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:

Project Completed.


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
JDRF International

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.