Supplementary Material for: Continuous erythropoietin receptor activator for the treatment of chronic dialysis patients with renal anemia in daily clinical practice in Poland: A non-interventional, multi-center, pragmatic NAVIGO trial

Background: Renal anemia is one of the most common complications of chronic kidney disease. This real-life study assessed the effectiveness of methoxy polyethylene glycol-epoetin beta, a continuous erythropoietin receptor activator (C.E.R.A.), for the treatment of chronic kidney disease (CKD)-associated anemia in patients receiving dialysis in daily clinical practice. Methods: 247 patients receiving chronic intermitted dialysis in 26 centers in Poland with CKD-associated symptomatic anemia, ESA-naïve, and with balanced iron stores in the investigators’ opinion were enrolled this real-life study. Over 12 months, the following data were collected: Hb concentration and dosage, route of administration and dosing scheme of C.E.R.A., dialysis adequacy, adverse events, iron therapy, and blood transfusions. Results: During the treatment, a Hb concentration of ≥10 g/dL was noted in 90.9% of hemodialysis patients (n=224) and 96.0% of peritoneal dialysis patients (n=23). At baseline, 7.8% of patients had a Hb concentration of 10–12 g/dL, which increased to 63.3% after 12 months. The median time when Hb concentration was maintained within 10–12 g/dL was 115.2 [IQR 49.1–188.7] days. A Hb concentration ≥12 g/dL was observed after 7 months of treatment in a maximum of 24.1% of hemodialysis patients, and 31.8% of peritoneal dialysis patients. The median time elapsed between the start of treatment and the first Hb concentration >10 g/dL was 42.0 [21.0–78.2] days. C.E.R.A. was well tolerated. Conclusions: C.E.R.A. corrects CKD-associated anemia in dialysis patients, and maintains Hb levels within the recommended target range. The study also confirmed the acceptable safety profile of the drug. Study identifier at ClinicalTrials.gov: NCT01690455