Lessons Learned from EVOLVE for Planning of Future Randomized Trials in Patients on Dialysis.

ABSTRACT: The effect of the calcimimetic cinacalcet on cardiovascular disease in patients undergoing hemodialysis with secondary hyperparathyroidism was assessed in the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events 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 hyperparathyroidism), importance of age for optimal stratification at randomization, use of unadjusted and adjusted intention-to-treat analysis for the primary outcome, how to resp

SUBMITTER: Parfrey PS 

PROVIDER: S-EPMC4791832 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature