Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis: A Randomized Controlled Trial.
Study Goal
The researchers aimed to compare the effectiveness and safety of less frequent, higher-dose ferric carboxymaltose versus more frequent, lower-dose iron sucrose for maintaining hemoglobin levels in hemodialysis patients.
Results Summary
Ferric carboxymaltose did not meet noninferiority for maintaining hemoglobin levels compared to iron sucrose, with greater declines in hemoglobin, ferritin, and transferrin saturation. Adverse events were similar between groups, though more infections occurred with iron sucrose.
Population
Patients on prevalent hemodialysis.
Effective Dosage
Equal cumulative doses of ferric carboxymaltose (less frequent, higher single doses) and iron sucrose (more frequent, lower single doses).
Duration
40 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
iron sucrose | decrease | hemoglobin | patients on prevalent hemodialysis | -0.27 g/dl | changed by | #1 |
ferric carboxymaltose | decrease | hemoglobin | patients on prevalent hemodialysis | -0.74 g/dl | changed by | #2 |
ferric carboxymaltose | decrease | hemoglobin changes compared with baseline | per-protocol population | -0.47 g/dl | differed by | #3 |
ferric carboxymaltose | decrease | ferritin | patients on prevalent hemodialysis | -31% | differed by | #4 |
ferric carboxymaltose | no change | transferrin | patients on prevalent hemodialysis | 1% | differed by | #5 |
ferric carboxymaltose | decrease | transferrin saturation | patients on prevalent hemodialysis | -27% | differed by | #6 |
Erythropoiesis-stimulating agent | no change | dosing | patients on prevalent hemodialysis | - | did not differ | #7 |
iron sucrose | increase | infections | patients on prevalent hemodialysis | - | more | #8 |
ferric carboxymaltose | no change | hemoglobin levels | patients on prevalent hemodialysis | - | did not meet noninferiority for maintaining | #9 |
BACKGROUND AND OBJECTIVES: Whether iron supplementation in patients on hemodialysis could be delivered by less frequent but higher single doses compared with the currently more common higher-frequency schedules of lower single iron doses is unknown. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We carried out an open-label, randomized, controlled noninferiority trial over 40 weeks in patients on prevalent hemodialysis ( RESULTS: In total, 108 patients completed the study. At 40 weeks, hemoglobin changed by -0.27 g/dl (95% confidence interval, -0.64 to 0.09) in the iron sucrose arm and by -0.74 g/dl (95% confidence interval, -1.1 to -0.39) in the ferric carboxymaltose arm compared with baseline. Noninferiority was not established in the per-protocol population as hemoglobin changes compared with baseline differed by -0.47 g/dl (95% confidence interval, -0.95 to 0.01) in the ferric carboxymaltose arm compared with the iron sucrose arm. Proportional changes from baseline to week 40 differed by -31% (98.3% confidence interval, -52 to -0.1) for ferritin, by 1% (98.3% confidence interval, -7 to 10) for transferrin, and by -27% (98.3% confidence interval, -39 to -13) for transferrin saturation in the ferric carboxymaltose arm compared with the iron sucrose arm. Erythropoiesis-stimulating agent dosing did not differ between groups. The overall number of adverse events was similar; however, more infections were observed in the iron sucrose arm. CONCLUSIONS: An equal cumulative dose of ferric carboxymaltose administered less frequently did not meet noninferiority for maintaining hemoglobin levels compared with iron sucrose administered more frequently. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients (COPEFER), NCT02198495.