A Phase 4 interventional study of Supplementation of ferric carboxymaltose and Supplementation of iron sucrose in Anemia of Chronic Kidney Disease, sponsored by Medical University of Vienna. Completed at 2 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment
Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with or without additional use of erythropoiesis-stimulating agents (ESA).
The investigators aim to compare two different intravenous iron preparations, ferric carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary objective is to assess whether both agents are equally effective to maintain a target haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin, transferrin saturation, and how much ESA therapy is administered.
Patients will be randomly assigned to either treatment group and followed in parallel over an active study period of 40 weeks.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 143 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30
Drug: Supplementation of ferric carboxymaltose
Supplementation of iron sucrose 100 mg at week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38
Drug: Supplementation of iron sucrose
Serum hemoglobin level (g/dl)
Time frame: 40 weeks
Serum ferritin level (µg/l)
Time frame: Week 0, 10, 20, 30, 40
Serum transferrin level (mg/dl)
Time frame: Week 0, 10, 20, 30, 40
Serum level of transferrin saturation (TSAT) (%)
Time frame: Week 0, 10, 20, 30, 40
ESA consumption in I.E./week or µg/week as appropriate
Time frame: Week 0, 10, 20, 30, 40
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna