C-Path, CDISC and TransCelerate announce availability of TA Standard for Kidney Transplantation

The Critical Path Institute (C-Path)Nov 3 2016

CDISC, C-Path, and TransCelerate Announce Therapeutic Area Standard for Kidney Transplant

The Clinical Data Interchange Standards Consortium (CDISC), Critical Path Institute (C-Path), and TransCelerate BioPharma, Inc. (TransCelerate), announce the open availability of a CDISC Therapeutic Area (TA) Standard for Kidney Transplantation. The Kidney Transplant v1.0 standard is focused on studies of therapeutic interventions to prevent rejection of transplanted kidneys in adult recipients.

Chronic kidney disease (CKD) includes conditions that damage kidneys and decrease their ability to maintain health. Twenty-six million American adults have CKD and millions of others are at increased risk. When kidneys fail, there are three treatment choices: hemodialysis, peritoneal dialysis, and kidney transplantation. According to the National Kidney Foundation, over 2 million people worldwide currently receive treatment with dialysis or a kidney transplant to stay alive.

This Therapeutic Area User Guide - Kidney Transplant (TAUG-KT) focuses on the key assessments and donor/recipient characteristics required to match donors with recipients, and to monitor post-transplant outcomes.

The TAUG- KT is the result of a collaborative effort among C-Path, CDISC, the US Food and Drug Administration (FDA), TransCelerate, the American Society of Nephrology (ASN), and the American Society of Transplantation (AST), as part of the Kidney Health Initiative (KHI). The mission of KHI, in partnership with the FDA and nephrology community, is "to advance scientific understanding of kidney health and patient safety implications of new and existing medical products and therapies, and to foster development of therapies for diseases that affect the kidney."

"It has been a pleasure working on this project with all the collaborators and assistance of C-Path and CDISC. This is the most comprehensive and up-to-date document in kidney transplantation. The diagrams and concept maps help distill down very complex issues in transplantation, such as the Banff criteria for kidney allograft rejection, into something that is understandable, teachable, and useful for all involved in kidney transplantation," states Daniel Brennan, MD, FACP, Director, Transplant Nephrology at Washington University School of Medicine in St. Louis.

Kidney Transplant v1.0 represents the first CDISC standard to address a therapeutic area in the field of solid organ transplant. Kidney Transplant v1.0 is available via the CDISC website, through User Guides, and the Shared Health and Research Electronic Library (SHARE), CDISC's metadata repository that facilitates electronic access to the standards and enables the reuse of common concepts across future TA standards.

With funding from FDA, the Kidney Transplant v1.0 standard was developed through the Coalition for Accelerating Standards and Therapies (CFAST).

CFAST, a joint initiative of CDISC and C-Path, was formed to accelerate clinical research and medical product development by creating and maintaining data standards, tools, and methods for conducting research in therapeutic areas important to public health, with invaluable support and advice from such organizations as the National Cancer Institute, Innovative Medicines Initiative, TransCelerate, and regulatory agencies including the FDA, Japan's Pharmaceutical and Medical Devices Agency, and the European Medicines Agency.

CDISC standards have been adopted and used in more than 90 countries, and will soon be required by regulatory authorities in the US and Japan. To date, TA Standards have been developed for over 25 different disease areas, with most being developed under the CFAST program. Use of these standards from the start of clinical research programs has proven capable of saving both time and resources. Researchers working in the area of kidney transplant are encouraged to implement these standards into their processes.