Kidney Health Initiative (KHI)

KHI Current Project

Pragmatic Trials in Dialysis: Challenges and Opportunities

Patient Care Issue:

Defining the benefit of a therapy in routine clinical experience is an important opportunity for kidney disease. There are almost 400,000 hemodialysis patients in the United States. This patient population has a mortality rate approaching 50% at three years from the start of hemodialysis, incurring Medicare expenditures in excess of $24 billion annually.

The TiME Trial is a large pragmatic clinical trial that is being conducted through the NIH Health Care Systems Research Collaboratory, a Common Fund initiative that aims to integrate clinical trials into healthcare delivery. The objective of the trial is to determine whether dialysis facility implementation of a hemodialysis session duration of at least 4.25 hours for incident patients improves clinical outcomes and quality of life.

Challenge:

Few randomized clinical trials have been conducted in this setting due to various perceived barriers – including FDA regulations related to data collection, lack of clarity around best practices for ensuring human subject protections, and cumbersome CMS requirements related to billing for patients involved in research.

KHI Solution:

KHI is supporting a workgroup comprised of TiME Trial investigators. The goal of the project is to provide the kidney community with information about the potential use of pragmatic trials to answer important clinical questions. In addition, the workgroup will recommend solutions to operational, regulatory, and business issues that may hinder routine conduct of clinical trials embedded in the provision of clinical care.

Status:

The workgroup's manuscript was electronically published in the Journal of the American Society of Nephrology (JASN) on July 11, 2016.

Deliverable:

Publication.

Timeframe for Completion:

Project Completed.

Workgroup:
Chair:

Laura M. Dember, MD
Hospital of the University of Pennsylvania

Members:

Patrick Archdeacon, MD (KHI Co-Chair)
Center for Drug Evaluation and Research, FDA

Mahesh Krishnan, MD, MPH, MBA, FASN (KHI Board of Directors)
DaVita Healthcare Partners

Eduardo Lacson, Jr., MD, MPH, FASN
Tufts Medical Center and formerly Fresenius Medical Care

Shari M. Ling, MD
Centers for Medicare and Medicaid Services

Prabir Roy-Chaudhury, MD, PhD, FASN (KHI Co-chair)
University of Arizona

Kimberly Smith, MD, MS
Center for Drug Evaluation and Research, FDA and formerly Centeres for Medicare and Medicaid Services


KHI Board of Directors Liaison:

Michael Flessner, MD, PhD
National Institute of Diabetes and Digestive and Kidney Diseases

Conflict of Interest:

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

To view the Workgroup's Disclosures please click here.

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