Table 2.

Lessons concerning imbalance in baseline covariates

(1) Randomization is not guaranteed to prevent significant imbalance in baseline clinical characteristics (even for a trial with nearly 4000 participants).
(2) Randomized controlled trials in CKD/ESRD should use both multivariable-adjusted ITT and unadjusted ITT analyses of the primary outcome.
(3) If there is risk of imbalance of baseline covariates, multivariable-adjusted ITT analysis should be used as the primary analysis on which the trial is judged (18).
(4) If participants across a broad age range are enrolled, stratification by age may be advisable because age is an important determinant of many outcomes. A similar argument could be made for other key covariates (e.g., baseline BP or proteinuria) depending on the outcome(s) of interest.
  • ITT, intention-to-treat.