PMID- 20190247 OWN - NLM STAT- MEDLINE DCOM- 20101028 LR - 20211020 IS - 1460-2385 (Electronic) IS - 0931-0509 (Print) IS - 0931-0509 (Linking) VI - 25 IP - 8 DP - 2010 Aug TI - The safety and efficacy of intravenous ferric carboxymaltose in anaemic patients undergoing haemodialysis: a multi-centre, open-label, clinical study. PG - 2722-30 LID - 10.1093/ndt/gfq069 [doi] AB - BACKGROUND: Patients with chronic kidney disease (CKD) often present with iron depletion and iron deficiency anaemia (IDA) because of frequent blood (and iron) loss. Therapy consists of repletion of iron stores and intravenous (i.v.) iron has become the standard care in this setting. However, older i.v. iron preparations have their limitations. This study primarily investigated the safety, and also the efficacy, of ferric carboxymaltose (FCM), a next-generation i.v. iron formulation, given as a bolus-push injection in patients with CKD undergoing maintenance haemodialysis (HD). METHODS: Patients (aged 18-65 years) with IDA undergoing HD received 100-200 mg of iron as FCM via an i.v. bolus-push injection into the HD venous line, two to three times weekly for or=1.0 g/dl increase in haemoglobin (Hb) from baseline at any time during the study. Enrolled patients (safety population) receiving >or=1 dose of study medication were included in the efficacy analyses [intent-to-treat (ITT) population]. RESULTS: Of 163 patients enrolled, 150 (92%) completed the study. The mean +/- SD total cumulative dose of iron as FCM administered was 2133.3 +/- 57.7 mg. In total, 193 AEs were reported in 89 out of 163 (54.6%) patients. Almost three-quarters of patients (73.6%) received erythropoiesis-stimulating agents (ESAs), but the dose remained stable during the study. Serious AEs occurred in 12 out of 163 (7.4%) patients and two patients died; none of these was considered by the investigator to be related to the study medication. Only five out of 163 (3.1%) patients discontinued study medication due to an AE. Overall, 100 out of 162 (61.7%; ITT population) patients were treatment responders, and mean Hb levels increased from 9.1 +/- 1.30 g/dl at baseline to 10.3 +/- 1.63 g/dl at follow-up. CONCLUSIONS: FCM is well-tolerated and effective in the correction of Hb levels and iron stores in patients with IDA undergoing HD. As changes in anaemia treatment other than i.v. FCM (e.g. increased ESA doses) were not permitted during the study, the clinically relevant increase in Hb in the majority of patients can be solely attributed to efficient iron utilization. The incidence of AEs was as expected for this population. FAU - Covic, Adrian AU - Covic A AD - Dialysis and Transplantation Center, Parhon University Hospital, Lasi, Romania. acovic@xnet.ro FAU - Mircescu, Gabriel AU - Mircescu G LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20100226 PL - England TA - Nephrol Dial Transplant JT - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JID - 8706402 RN - 0 (Ferric Compounds) RN - 0 (Hematinics) RN - 0 (Hemoglobins) RN - 6897GXD6OE (ferric carboxymaltose) RN - 69-79-4 (Maltose) RN - 9007-73-2 (Ferritins) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Anemia, Iron-Deficiency/blood/*drug therapy/etiology MH - Dose-Response Relationship, Drug MH - Female MH - Ferric Compounds/administration & dosage/*adverse effects/*therapeutic use MH - Ferritins/blood MH - Hematinics/therapeutic use MH - Hemoglobins/metabolism MH - Humans MH - Injections, Intravenous MH - Kidney Diseases/blood/complications/*therapy MH - Male MH - Maltose/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use MH - Middle Aged MH - *Renal Dialysis MH - Treatment Outcome MH - Young Adult PMC - PMC2905444 EDAT- 2010/03/02 06:00 MHDA- 2010/10/29 06:00 PMCR- 2010/02/26 CRDT- 2010/03/02 06:00 PHST- 2010/03/02 06:00 [entrez] PHST- 2010/03/02 06:00 [pubmed] PHST- 2010/10/29 06:00 [medline] PHST- 2010/02/26 00:00 [pmc-release] AID - gfq069 [pii] AID - 10.1093/ndt/gfq069 [doi] PST - ppublish SO - Nephrol Dial Transplant. 2010 Aug;25(8):2722-30. doi: 10.1093/ndt/gfq069. Epub 2010 Feb 26.