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 1 Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
≥18 years of age	Age < 18 years
Chronic kidney disease (CKD) stages 3–5 (glomerular filtration rate < 60 mL/min per 1.73 m²)	No renal failure or CKD stages 1–2
Written and signed informed patient consent and ability to co-operate with study protocol	Patients unable or do not wish to give consent or inability to co-operate with study protocol
No previous iron administration in last 6 weeks	Parenteral iron therapy within previous 6 weeks
Serum ferritin level less than 200 μg/L	Ferritin greater than 200 μg/L
Transferrin saturation < 20%	Transferrin saturation > 40%
Non-smoker or ex-smoker	Current smokers
	Hemochromatosis
	Patients with potential confounding factors to neutrophil gelatinase–associated lipocalin (NGAL) measurement (cancer, infection)
	Pregnancy
	Patients being investigated for potential blood loss
	Patients with a hematological malignancy/ hemolysis or known hemaglobinopathy, including myeloma
	Known allergy to any iron therapy

ISSN: 1745-6215