2.1. Study Design
end-stage renal disease, CKD
END-STAGE RENAL DISEASE
This study was a single-center, prospective, randomized, open-label, controlled, parallel-group trial that was carried out with pre-dialysis stage 4–5 CKD patients during a 4-week study period. Patients were recruited over a period of 8 months from the end-stage renal disease program database within the renal clinical service department of Taichung Veterans General Hospital during the period from April to December 2020. Eligible participants were assigned at a 1:1 ratio to either the HE-LPF group or the control group using computer-generated randomization to receive either the study intervention or a control comparator. The study was carried out according to the current version of the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines, with reference to a study protocol approved by the Institutional Review Board of Taichung Veterans General Hospital (IRB approved number SF20045B). Signed and dated informed consent was obtained from all patients prior to enrollment in the study. The trial was registered at ClinicalTrials.gov (NCT05330663).