Trial design
infection, death
RENAL, INFECTION, KIDNEY, ADVERSE EVENTS
A single-center, double-blinded, post-hoc superiority, randomized controlled trial was conducted at Thammasat University Hospital from July 2019 to February 2021. The trial protocol was approved by the Human Research Ethics Committee of Thammasat University No 1 (Faculty of Medicine): MTU-EC-OO-4-055/62 and followed the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. Written informed consent was obtained from all eligible participants, and the protocol was registered in the Thai Clinical Trials Registry with study number TCTR20190707001 (Date of registration 07/07/2019). This trial was funded by the Kidney Foundation of Thailand and the Research Group in Nephrology and Renal Replacement Therapy, Faculty of Medicine, Thammasat University. Study data were collected and managed using REDCap electronic data capture tools hosted at the Faculty of Medicine, Thammasat University, ThailandRandom allocation was done by computer-generated permuted blocks of varying sizes (blocks of 2 and 4). Randomization was stratified by the level of baseline Hb: < 10, 10–12 and > 12 g/dl. The investigators generated a random allocation sequence, enrolled participants, and assigned treatments. The patients were randomly assigned in a 1:1 to receive either a single, monthly dose of 100 mg or 200 mg IV iron sucrose. Since iron sucrose was mixed with 100-ml saline bags and dripped in 30 min during hemodialysis sessions, patients and care physicians cannot distinguish between both regimens (double-blinded).After randomization, trial visits were conducted every month up until 12 months. Hb levels were measured monthly; if levels were below or above target levels of 10–12 g/dl, ESA doses were adjusted to either increase or decrease ~ 25% of previous amounts. A blood transfusion would be given if Hb levels were extremely low (usually < 8 g/dl) or anemic symptoms were presented. Ferritin levels and TSAT were measured every three months and maintained in the safety ranges: ferritin 200–700 ng/dl and TSAT 20–40%. Suppose ferritin levels > 700 ng/dl or TSAT > 40%, IV iron was withheld for one month or longer until levels declined below those safety margins. Iron therapy was temporarily withheld if patients had a systemic or severe infection. In patients with absolute IDA, defined as ferritin levels < 200 ng/dl or TSAT < 20%, the treatment was unblinded, and IV iron sucrose was prescribed to be 100 mg weekly for a total of 10 doses (rescue regimen). After this, these patients would receive 200 mg IV iron monthly until the end of the study. Quality of life, measured by the EQ-5D questionnaire, was evaluated every six months. The incidence of death, hospitalizations, and adverse events were recorded throughout the study.