Protocol and baseline data for a prospective open-label explorative randomized single-center comparative study to determine the effects of various intravenous iron preparations on markers of oxidative stress and kidney injury in chronic kidney disease (IRON-CKD)

Table 2 Summary of schedule detailing all of the assessments required at each visit

Procedures	Visit 1	Visit 2a	Visit 2b	Visit 3	Visit 4	Visit 5	Visit 6
Procedures	Screen	baseline	Post iron 2 h	1 day	1 week	1 month	3 month
Informed consent	x
Demographics	X
History	X
Examination	X				X	X	X
Weight	X	X		X	X	X	X
BCP	X	X	X	X	X	X	X
Albumin	X	X	X	X	X	X	X
eGFR	X	X	X	X	X	X	X
FBC	X	X	X	X	X	X	X
Ferritin	X	X	X	X	X	X	X
TS%	X	X	X	X	X	X	X
CRP	X	X	X	X	X	X	X
Cystatin C		X	X	X	X	X	X
uACR/uPCR		X	X	X	X	X	X
NGAL		X	X	X	X	X	X
Oxidative stress markers		X	X	X	X	X	X
Pulse wave velocity		X	X	X	X	X	X
SF-36		X			X	X	X
Medication check		X			X	X	X
Adverse events			X	X	X	X	X

“X” indicates action to be taken or an investigation to be performed
Abbreviations: BCP biochemical profile (consisting of urea and electrolytes, creatinine, liver function tests, albumin, total protein, calcium, phosphate, and bicarbonate), CRP C-reactive protein, eGFR estimated glomerular filtration rate, FBC full blood count (consisting of hemoglobin, white cell count, platelets, mean cell volume, and mean cell hemoglobin concentration), NGAL neutrophil gelatinase–associated lipocalin, SF-36 36-Item Short Form Health Survey, TS% transferrin saturation percentage, uACR/uPCR urinary albumin:creatinine ratio/urinary protein:creatinine ratio

ISSN: 1745-6215