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Lessons learned from EVOLVE for the planning of future global randomized trials in chronic kidney disease

Parfrey, PS; Block, GA; Correa-Rotter, R; Drueke, TB; Floege, J; Herzog, CA; London, GM; ... Chertow, GM; + view all (2016) Lessons learned from EVOLVE for the planning of future global randomized trials in chronic kidney disease. Clinical Journal of the American Society of Nephrology , 11 (3) pp. 539-546. 10.2215/CJN.06370615. Green open access

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Abstract

The effect of the calcimimetic cinacalcet on cardiovascular disease in patients undergoing hemodialysis with secondary hyperparathyroidism (sHPT) was evaluated in the EVOLVE trial. This was the largest (in size) and longest (in duration) randomized controlled clinical trial undertaken in this population. During planning, execution, analysis and reporting of the trial many lessons were learned, including those related to the use of a composite cardiovascular primary endpoint, definition of endpoints (particularly heart failure and severe unremitting HPT), importance of age for optimal stratification at randomization, use of unadjusted and adjusted intention-to-treat analysis for the primary outcome, how to respond to a lower than predicted event rate during the trial, development of a pre-specified analytic plan that accounted for non-adherence and for co-interventions that diminished the power of the trial to observe a treatment effect, determination of the credibility of a subgroup effect, use of adverse effects database to investigate rare diseases, collection of blood for biomarker measurement not designated prior to trial initiation, and interpretation of the benefits to harms ratio for individual patients. It is likely that many of these issues will arise in planning of future trials in chronic kidney disease.

Type: Article
Title: Lessons learned from EVOLVE for the planning of future global randomized trials in chronic kidney disease
Location: US
Open access status: An open access version is available from UCL Discovery
DOI: 10.2215/CJN.06370615
Publisher version: http://dx.doi.org/10.2215/CJN.06370615
Language: English
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Renal Medicine
URI: https://discovery.ucl.ac.uk/id/eprint/1472692
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