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Effective achievement of hemoglobin stability with once-monthly C.E.R.A. in peritoneal dialysis patients: a prospective study.

Koch M, Treiber W, Fliser D - Clin Drug Investig (2013)

Bottom Line: The primary efficacy variable, all measured Hb values in the range 11-12 g/dL, was 18.4 % (34/185) and 14.8 % (24/162) in the efficacy and modified efficacy populations, respectively.The mean (SD) maximum intra-individual fluctuation in Hb level was 0.56 (0.50) g/dL in the efficacy population and 0.58 (0.49) g/dL in the modified efficacy population, with maximum intra-individual fluctuation ≤1 g/dL in 85.4 % (158/185) and 83.3 % (135/162) of patients, respectively.No adverse drug reactions were reported during the study.

View Article: PubMed Central - PubMed

Affiliation: Nephrology Center, Gartenstrasse 8, 40822, Mettmann, Germany, koch@dialyse-mettmann.de.

ABSTRACT

Background: Correction of low hemoglobin (Hb) levels is associated with improved survival and greater quality of life in dialysis patients, but frequent administration of erythropoiesis stimulating agent (ESA) therapy is unsatisfactory for peritoneal dialysis patients.

Objective: The objective of this study was to assess Hb stability in an unselected population of maintenance peritoneal dialysis patients receiving once-monthly treatment with C.E.R.A., a continuous erythropoietin receptor activator.

Methods: In a prospective, non-interventional, single-arm study at 33 Germany dialysis centers, peritoneal dialysis patients with or without ESA treatment prior to study entry received once-monthly treatment with C.E.R.A. Hb stability was assessed by the proportion of patients for whom all measured Hb values during months 6-8 (the evaluation phase) were within the range 11-12, 11-13, 10-12 or 11-12.5 g/dL.

Results: 220 patients received at least one dose of C.E.R.A. During the evaluation phase, 185 patients provided ≥1 Hb measurement (efficacy population) and 162 patients provided ≥2 Hb measurements (the modified efficacy population). The mean (SD) time between C.E.R.A. doses was 28.2 (7.2) days and mean (SD) C.E.R.A. dose was 109 (57) μg per application. Mean (SD) Hb level was 11.1 (1.4) g/dL at baseline and 11.5 (1.3) g/dL at the end of the study (modified efficacy population). The primary efficacy variable, all measured Hb values in the range 11-12 g/dL, was 18.4 % (34/185) and 14.8 % (24/162) in the efficacy and modified efficacy populations, respectively. The mean (SD) maximum intra-individual fluctuation in Hb level was 0.56 (0.50) g/dL in the efficacy population and 0.58 (0.49) g/dL in the modified efficacy population, with maximum intra-individual fluctuation ≤1 g/dL in 85.4 % (158/185) and 83.3 % (135/162) of patients, respectively. No adverse drug reactions were reported during the study.

Conclusion: In this large population of maintenance peritoneal dialysis patients, once-monthly administration of C.E.R.A. achieved a high degree of Hb stability and was well-tolerated.

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Mean (SD) hemoglobin level in all patients, in patients without any erythropoiesis stimulating agent (ESA) therapy prior to study entry, and in patients who received an ESA therapy other than continuous erythropoietin receptor activator (C.E.R.A.) prior to study entry (modified efficacy population, n = 162)
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Fig2: Mean (SD) hemoglobin level in all patients, in patients without any erythropoiesis stimulating agent (ESA) therapy prior to study entry, and in patients who received an ESA therapy other than continuous erythropoietin receptor activator (C.E.R.A.) prior to study entry (modified efficacy population, n = 162)

Mentions: Mean (SD) Hb level was 11.1 (1.4) g/dL at baseline and 11.5 (1.3) g/dL at the end of the study (modified efficacy population) (Fig. 2). A small initial rise after study entry was attributed to the 53 patients who were not previously receiving ESA therapy prior to study, in whom mean (SD) Hb increased from 11.0 (1.4) g/dL at baseline to 11.5 (1.4) g/dL one month after initiation of C.E.R.A. therapy and 11.3 (1.5) g/dL at month 9. For the 106 patients who were receiving non-C.E.R.A. ESA treatment prior to the study, mean (SD) Hb level was 11.3 (1.3) g/dL at baseline, 11.5 (1.2) g/dL after one month and 11.7 (1.0) g/dL at month 9.Fig. 2


Effective achievement of hemoglobin stability with once-monthly C.E.R.A. in peritoneal dialysis patients: a prospective study.

Koch M, Treiber W, Fliser D - Clin Drug Investig (2013)

Mean (SD) hemoglobin level in all patients, in patients without any erythropoiesis stimulating agent (ESA) therapy prior to study entry, and in patients who received an ESA therapy other than continuous erythropoietin receptor activator (C.E.R.A.) prior to study entry (modified efficacy population, n = 162)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3775191&req=5

Fig2: Mean (SD) hemoglobin level in all patients, in patients without any erythropoiesis stimulating agent (ESA) therapy prior to study entry, and in patients who received an ESA therapy other than continuous erythropoietin receptor activator (C.E.R.A.) prior to study entry (modified efficacy population, n = 162)
Mentions: Mean (SD) Hb level was 11.1 (1.4) g/dL at baseline and 11.5 (1.3) g/dL at the end of the study (modified efficacy population) (Fig. 2). A small initial rise after study entry was attributed to the 53 patients who were not previously receiving ESA therapy prior to study, in whom mean (SD) Hb increased from 11.0 (1.4) g/dL at baseline to 11.5 (1.4) g/dL one month after initiation of C.E.R.A. therapy and 11.3 (1.5) g/dL at month 9. For the 106 patients who were receiving non-C.E.R.A. ESA treatment prior to the study, mean (SD) Hb level was 11.3 (1.3) g/dL at baseline, 11.5 (1.2) g/dL after one month and 11.7 (1.0) g/dL at month 9.Fig. 2

Bottom Line: The primary efficacy variable, all measured Hb values in the range 11-12 g/dL, was 18.4 % (34/185) and 14.8 % (24/162) in the efficacy and modified efficacy populations, respectively.The mean (SD) maximum intra-individual fluctuation in Hb level was 0.56 (0.50) g/dL in the efficacy population and 0.58 (0.49) g/dL in the modified efficacy population, with maximum intra-individual fluctuation ≤1 g/dL in 85.4 % (158/185) and 83.3 % (135/162) of patients, respectively.No adverse drug reactions were reported during the study.

View Article: PubMed Central - PubMed

Affiliation: Nephrology Center, Gartenstrasse 8, 40822, Mettmann, Germany, koch@dialyse-mettmann.de.

ABSTRACT

Background: Correction of low hemoglobin (Hb) levels is associated with improved survival and greater quality of life in dialysis patients, but frequent administration of erythropoiesis stimulating agent (ESA) therapy is unsatisfactory for peritoneal dialysis patients.

Objective: The objective of this study was to assess Hb stability in an unselected population of maintenance peritoneal dialysis patients receiving once-monthly treatment with C.E.R.A., a continuous erythropoietin receptor activator.

Methods: In a prospective, non-interventional, single-arm study at 33 Germany dialysis centers, peritoneal dialysis patients with or without ESA treatment prior to study entry received once-monthly treatment with C.E.R.A. Hb stability was assessed by the proportion of patients for whom all measured Hb values during months 6-8 (the evaluation phase) were within the range 11-12, 11-13, 10-12 or 11-12.5 g/dL.

Results: 220 patients received at least one dose of C.E.R.A. During the evaluation phase, 185 patients provided ≥1 Hb measurement (efficacy population) and 162 patients provided ≥2 Hb measurements (the modified efficacy population). The mean (SD) time between C.E.R.A. doses was 28.2 (7.2) days and mean (SD) C.E.R.A. dose was 109 (57) μg per application. Mean (SD) Hb level was 11.1 (1.4) g/dL at baseline and 11.5 (1.3) g/dL at the end of the study (modified efficacy population). The primary efficacy variable, all measured Hb values in the range 11-12 g/dL, was 18.4 % (34/185) and 14.8 % (24/162) in the efficacy and modified efficacy populations, respectively. The mean (SD) maximum intra-individual fluctuation in Hb level was 0.56 (0.50) g/dL in the efficacy population and 0.58 (0.49) g/dL in the modified efficacy population, with maximum intra-individual fluctuation ≤1 g/dL in 85.4 % (158/185) and 83.3 % (135/162) of patients, respectively. No adverse drug reactions were reported during the study.

Conclusion: In this large population of maintenance peritoneal dialysis patients, once-monthly administration of C.E.R.A. achieved a high degree of Hb stability and was well-tolerated.

Show MeSH
Related in: MedlinePlus