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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric carboxymaltose | Active Comparator | Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30 |
|
| Iron sucrose | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplementation of ferric carboxymaltose | Drug |
| ||
| Supplementation of iron sucrose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum hemoglobin level (g/dl) | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ferritin level (µg/l) | Week 0, 10, 20, 30, 40 | |
| Serum transferrin level (mg/dl) | Week 0, 10, 20, 30, 40 | |
| Serum level of transferrin saturation (TSAT) (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gere Sunder-Plassmann, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Division of Nephrology and Dialysis | Vienna | 1090 | Austria | |||
| Wiener Dialysezentrum GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34470831 | Derived | Bielesz B, Lorenz M, Monteforte R, Prikoszovich T, Gabriel M, Wolzt M, Gleiss A, Horl WH, Sunder-Plassmann G. Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2021 Oct;16(10):1512-1521. doi: 10.2215/CJN.03850321. Epub 2021 Sep 1. |
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| Drug |
|
| Week 0, 10, 20, 30, 40 |
| ESA consumption in I.E./week or µg/week as appropriate | Week 0, 10, 20, 30, 40 |
| Vienna |
| 1220 |
| Austria |