UH3 Project: Time to Reduce Mortality in End-Stage Renal Disease (TiME)
Principal Investigator: Laura Dember, MD
Sponsoring Institution: University of Pennsylvania
NIH Institute Providing Oversight: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Program Official: Paul Kimmel (NIDDK)
Project Scientist: Kevin Abbott (NIDDK)
ClinicalTrials.gov Identifier: NCT02019225
Study Locations: Dialysis facilities throughout the United States
Trial Status: Terminated
TiME is a large pragmatic, cluster-randomized clinical trial testing a simple intervention to improve survival and quality of life for patients with kidney failure who require chronic treatment with dialysis. The trial evaluates a minimum hemodialysis session duration of 4.25 hours compared with usual care for patients with end-stage renal disease initiating treatment with thrice weekly maintenance hemodialysis.
The TiME trial is conducted through a partnership between academic investigators and 2 large dialysis provider organizations in approximately 320 dialysis facilities. The pragmatic design of the trial, the use of multiple electronic health record systems for trial implementation, and the partnership between academia and industry will establish a framework for conducting research within health care delivery systems that will be relevant to a broad range of diseases and research questions.