Kidney Health Initiative (KHI)

KHI Current Project

Data Harmonization in Kidney Transplant

Patient Care Issue:

Currently, there are over 90,000 individuals waiting for a kidney transplant, with over 80% of those on the waiting list are on dialysis. On average, an individual’s life expectancy can double after they receive a kidney transplant.

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.

KHI Soultion:

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 partner with these groups and help define appropriate standards in the therapeutic area of kidney transplant. KHI’s specific role is providing clinical and medical expertise.


Taken from: CDISC Therapeutic Area Standards Development Process: CFAST Roles, Responsibilities, Skills and Resource Allocation

Status:

The CFAST/ CDISC/ KHI team's open comment period closes on Monday, August 1, after which the team will review the comments submitted by the public.

Deliverable:

CDISC Therapeutic Area User Guide for Kidney Transplant (including concept maps, SHARE metadata, SDTM-IG type examples, CDASH annotated CRF examples, and CDASH metadata examples).

Timeframe for Completion:

Late 2016.

Workgroup:
Co-Chairs:

Rita Alloway, PharmD, FCCP
Division of Nephrology and Hypertension University of Cincinnati

Roslyn B. Mannon, MD, FASN
University of Alabama at Birmingham


Members

Beatrice Concepcion, MD
Division of Nephrology and Hypertension
Vanderbilt University School of Medicine

Daniel C. Brennan, MD
Washington University School of Medicine

Amit Govil, MD, FASN
Division of Nephrology and Hypertension
University of Cincinnati Medical Center

Rowena Delos Santos, MD, FASN
Division of Nephrology Washington University in St. Louis


Conflict of Interest

To view KHI's Conflict of Interest and Disclosure Policy, please click here.

If you have any questions, please do not hesitate to contact KHI at khi@asn-online.org.