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Rajiv Agarwal; Defining end-stage renal disease in clinical trials: Unlike definition of stroke and myocardial infarction, there is no uniformly agreed upon definition to adjudicate end-stage renal disease ESRD. ESRD remains the most unambiguous and clinically relevant end point for clinical trialists, regulators, payers and patients with chronic kidney disease.

The prescription of dialysis to patients with advanced chronic kidney disease is subjective and great variations exist among physicians ezrd countries. However, this definition is still a surrogate since many patients may live years without being symptomatic or needing dialysis.

The purpose of this report is to describe a framework to define when the kidney function ends and when ESRD can be adjudicated. Discussed in this report are i the importance of diagnosing symptomatic uremia or advanced asymptomatic uremia thus establishing the need for dialysis; ii establishing the chronicity of dialysis so as to distinguish it from acute dialysis; iii establishing ESRD when dialysis is unavailable, refused or considered futile and iv the adjudication process.


Several challenges and ambiguities that emerge in clinical trials and their possible solutions are provided. The criteria proposed herein may help to standardize the definition of ESRD and reduce the variability in adjudicating the most important renal end point in clinical trials of chronic kidney disease. Oxford University Press is a department of the University of Oxford.

It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Close mobile search navigation Article navigation. Defining end-stage renal disease in clinical trials: Correspondence and offprint requests to: Abstract Unlike definition of stroke and myocardial infarction, there is no uniformly agreed upon definition to adjudicate end-stage renal disease ESRD.

Diabetes and end-stage renal disease; a review article on new concepts

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Diabetes and end-stage renal disease; a review article on new concepts

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