Methods
primary kidney disease
Details of EMPA-KIDNEY’s rationale, design, protocol, pre-specified
data analysis plan, and main results have been reported previously.All eligible and consenting participants entered a pre-randomization run-in
phase and were provided with a 15-week supply of once daily placebo tablets. During
this time, local investigators reviewed screening data, assessed current
RAS-inhibitor use, and approved potential participants for later randomization.
Participant-reported primary kidney disease was confirmed by local lead
investigators. Throughout the trial, clinical responsibility for participants
remained with their local doctors. After completing the run-in, willing and eligible
participants had central samples of blood and urine collected for central analysis
and long-term storage, and were randomly allocated to receive empagliflozin (10 mg
once daily) or matching placebo.