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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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Proportion of patients within pre-specified hemoglobin (Hb) ranges during the evaluation phase (months 6–8). The efficacy population consisted of patients with at least one Hb value during the evaluation phase (n = 185). The modified efficacy population consisted of all patients in the efficacy population for whom at least two Hb measurements were available during the evaluation period (n = 162)
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Fig3: Proportion of patients within pre-specified hemoglobin (Hb) ranges during the evaluation phase (months 6–8). The efficacy population consisted of patients with at least one Hb value during the evaluation phase (n = 185). The modified efficacy population consisted of all patients in the efficacy population for whom at least two Hb measurements were available during the evaluation period (n = 162)

Mentions: Figure 3 illustrates the proportion of patients with all available Hb values within pre-specified ranges during the evaluation phase. The proportion of patients in the range 11–12 g/dL during the evaluation phase, i.e. the primary efficacy variable, was 18.4 % (34/185) of patients in the efficacy population for whom Hb measurements were provided, and 14.8 % (24/162) in the modified efficacy population. During the evaluation phase, approximately 40 % of patients in the efficacy and the modified efficacy populations had all measured Hb levels within the 10–12 or 11–13 g/dL ranges (Fig. 3). Among the 115 patients in the modified efficacy population who did not receive C.E.R.A. prior to study entry, 13.9 % (16/115), 38.3 % (44/115) and 38.3 % (44/115) had all Hb values within the ranges 11–12, 10–12 and 11–13 g/dL, respectively. During the evaluation period, approximately 83 % of patients had all Hb values ≥10 g/dL and 87 % of patients had all Hb values ≤13 g/dL in both the efficacy and modified efficacy populations (Fig. 3).Fig. 3


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)

Proportion of patients within pre-specified hemoglobin (Hb) ranges during the evaluation phase (months 6–8). The efficacy population consisted of patients with at least one Hb value during the evaluation phase (n = 185). The modified efficacy population consisted of all patients in the efficacy population for whom at least two Hb measurements were available during the evaluation period (n = 162)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig3: Proportion of patients within pre-specified hemoglobin (Hb) ranges during the evaluation phase (months 6–8). The efficacy population consisted of patients with at least one Hb value during the evaluation phase (n = 185). The modified efficacy population consisted of all patients in the efficacy population for whom at least two Hb measurements were available during the evaluation period (n = 162)
Mentions: Figure 3 illustrates the proportion of patients with all available Hb values within pre-specified ranges during the evaluation phase. The proportion of patients in the range 11–12 g/dL during the evaluation phase, i.e. the primary efficacy variable, was 18.4 % (34/185) of patients in the efficacy population for whom Hb measurements were provided, and 14.8 % (24/162) in the modified efficacy population. During the evaluation phase, approximately 40 % of patients in the efficacy and the modified efficacy populations had all measured Hb levels within the 10–12 or 11–13 g/dL ranges (Fig. 3). Among the 115 patients in the modified efficacy population who did not receive C.E.R.A. prior to study entry, 13.9 % (16/115), 38.3 % (44/115) and 38.3 % (44/115) had all Hb values within the ranges 11–12, 10–12 and 11–13 g/dL, respectively. During the evaluation period, approximately 83 % of patients had all Hb values ≥10 g/dL and 87 % of patients had all Hb values ≤13 g/dL in both the efficacy and modified efficacy populations (Fig. 3).Fig. 3

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