BackgroundIron deficiency anaemia is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer®) and oral iron in NDD-CKD patients with renal-related anaemia.MethodsThe trial was a Phase III open-label, comparative, multicentre, non-inferiority trial conducted in 351 iron-deficient NDD-CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B). The patients in Group A were randomized into A1 (infusion of max. 1000 mg single doses over 15 min) and A2 (bolus injections of 500 mg over 2 min). A modified Ganzoni formula was used to calculate IV iron need. The primary end point was change in haemoglobin concentrations from baseline to Week 4.ResultsIron isomaltoside 1000 was both non-inferior to oral iron at Week 4 (P < 0.001) and sustained a superior increase in haemoglobin from Week 3 until the end of the study at Week 8 (P = 0.009 at Week 3). The haemoglobin response was more pronounced with iron isomaltoside 1000 doses ≥1000 mg (P < 0.05). Serum-ferritin and transferrin saturation concentrations were also significantly increased with IV iron. Adverse drug reactions were observed in 10.5% in the iron isomaltoside 1000 group and 10.3% in the oral iron group. More patients treated with oral iron sulphate withdrew from the study due to adverse events (4.3 versus 0.9%, P = 0.2).ConclusionsIron isomaltoside 1000 was more efficacious than oral iron for increase in haemoglobin and proved to be well tolerated at the tested dose levels in NDD-CKD patients.

Introduction: End-stage renal disease (ESRD) is associated with exponentially elevated cardiovascular mortality. Arterial stiffness (AS) – usually expressed with pulse wave velocity (PWV) – is an established independent predictor of cardiovascular risk beyond the traditional risk factors. Higher PWV values are frequently observed in patients with ESRD. Due to the intrinsic physiologic relationship between PWV and prevailing arterial pressure, PWV can change without relevant changes in the arterial wall structure, and thus an individual pressure-independent expression of PWV is essential. Methods: The study is a single-center observational study. Repeated measurements of blood pressure (BP) and pulse wave analysis were performed during each dialysis session of 1 week. Aortic PWV was then adjusted to 120 mm Hg central systolic BP (PWV120) based on individually determined relationship. PWV120 values were compared between single sessions. Calculation of the PWV120 was performed retrospectively. Results: Fifty-four subjects were included, 61.1% of whom were male. The median age was 75.5 years, and median dialysis vintage was 33.1 months. Mean systolic/diastolic BP was 121.4/70.5 mm Hg, and the median heart rate was 64.6 beats/min. Mean PWV was 10.9 m/s, and mean PWV120 was 11.3 m/s. PWV120 did not change across single dialysis session during 1 week, while systolic, diastolic BP, PWV, and ultrafiltration volume differed significantly. Discussion/Conclusions: Our data suggest that true AS does not change in the short-term course in dialysis patients. The observed changes in PWV are rather associated with BP change due to intrinsic pressure dependence. Our analytical approach represents a novel method for this purpose, which is easy in performance and also applicable for large interventional trials and clinical practice.

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