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An Observational Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis — PROSTARRT  

Chronic Kidney Disease Clinical Trial

Official title:
A Prospective, Observational, Randomized Comparative Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis

Clinical Trial Summary

The purpose of the study is to compare the 90 day and 12 month composite end point of death (all-cause mortality) and hospitalization in incident hemodialysis patients randomized to receive support from a dedicated case manager (intervention group) versus those not receiving support from a dedicated case manager (control group).

Clinical Trial Description

This is multicenter, prospective, observational, and randomized (the study drug is assigned by chance), 1-year study, in academic and community-based nephrology clinical practices that will examine the impact of a facility nurse case manager. In this study a group of patients guideline- based, algorithm- driven approach to hemodialysis initiation with targets (as per Canadian Society of Nephrology and/or International guidelines) will be used with facility nurse case manager and in control group same approach will be used without facility nurse case manager. Patients will be treated with any approved erythropoiesis stimulating agent for the correction of anemia, according to guidance in the current approved product monographs. All treatments will be prescribed by the physician according to actual clinical practice or standard of care for chronic kidney disease. The entire study duration for each participant will be approximately 12 months. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01613404
Study type Observational
Source Janssen Inc.
Contact
Status Completed
Phase Phase 4
Start date February 2012
Completion date December 2014
View Details
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