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Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study.

Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloëguen C, Beyer U, STRIATA Study Investigato - Nephrol. Dial. Transplant. (2008)

Bottom Line: Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis.Both treatments were well tolerated.Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.

View Article: PubMed Central - PubMed

Affiliation: Hôpital Lapeyronie, Service de Nephrologie, Montpellier, France. b-canaud@chu-montpellier.fr

ABSTRACT

Background: Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life ( approximately 130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis.

Methods: STRIATA (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment for Anaemia) was a multicentre, open-label randomized phase III study to evaluate the efficacy and safety of intravenous C.E.R.A. administered once every 2 weeks (Q2W) for Hb maintenance following direct conversion from darbepoetin alfa (DA). Adult patients on dialysis receiving stable intravenous DA once weekly (QW) or Q2W were randomized (1:1) to continue their current DA regimen (n = 156) or receive intravenous C.E.R.A. Q2W (n = 157) for 52 weeks. Doses were adjusted to maintain Hb levels within +/- 1.0 g/dl of baseline and between 10.0 and 13.5 g/dl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 29-36).

Results: Most patients (>80%) received DA QW before randomization. The mean (95% CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 g/dl (-0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. Both treatments were well tolerated.

Conclusions: Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.

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Related in: MedlinePlus

Individual stability of Hb mean levels (intent-to-treat population). No formal test was conducted to assess the statistical significance of between-group differences; however, the overlapping SD bars suggest any difference would not be significant. DA, darbepoetin alfa; QW, once weekly; Q2W, once every 2 weeks; Hb, haemoglobin; SD, standard deviation.
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Figure 5: Individual stability of Hb mean levels (intent-to-treat population). No formal test was conducted to assess the statistical significance of between-group differences; however, the overlapping SD bars suggest any difference would not be significant. DA, darbepoetin alfa; QW, once weekly; Q2W, once every 2 weeks; Hb, haemoglobin; SD, standard deviation.

Mentions: During the evaluation period, mean Hb values were maintained within +1 g/dl of baseline in a similar proportion of patients treated with C.E.R.A. and DA (65.5 and 71.8% of patients in the C.E.R.A. and DA groups, respectively, P = 0.2502, chi-square test). Assessment of the mean standard deviation of Hb revealed similar intrapatient Hb variability in the C.E.R.A. and DA groups during the titration (0.86 versus 0.76 g/dl), evaluation (0.63 versus 0.53 g/dl) and safety observation (0.71 versus 0.66 g/dl) periods (Figure 5). These findings are consistent with the primary efficacy assessment and support the view that Hb control was successfully maintained following conversion to C.E.R.A. in patients who were predominantly (>80%) receiving QW DA before randomization.


Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study.

Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloëguen C, Beyer U, STRIATA Study Investigato - Nephrol. Dial. Transplant. (2008)

Individual stability of Hb mean levels (intent-to-treat population). No formal test was conducted to assess the statistical significance of between-group differences; however, the overlapping SD bars suggest any difference would not be significant. DA, darbepoetin alfa; QW, once weekly; Q2W, once every 2 weeks; Hb, haemoglobin; SD, standard deviation.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2568005&req=5

Figure 5: Individual stability of Hb mean levels (intent-to-treat population). No formal test was conducted to assess the statistical significance of between-group differences; however, the overlapping SD bars suggest any difference would not be significant. DA, darbepoetin alfa; QW, once weekly; Q2W, once every 2 weeks; Hb, haemoglobin; SD, standard deviation.
Mentions: During the evaluation period, mean Hb values were maintained within +1 g/dl of baseline in a similar proportion of patients treated with C.E.R.A. and DA (65.5 and 71.8% of patients in the C.E.R.A. and DA groups, respectively, P = 0.2502, chi-square test). Assessment of the mean standard deviation of Hb revealed similar intrapatient Hb variability in the C.E.R.A. and DA groups during the titration (0.86 versus 0.76 g/dl), evaluation (0.63 versus 0.53 g/dl) and safety observation (0.71 versus 0.66 g/dl) periods (Figure 5). These findings are consistent with the primary efficacy assessment and support the view that Hb control was successfully maintained following conversion to C.E.R.A. in patients who were predominantly (>80%) receiving QW DA before randomization.

Bottom Line: Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis.Both treatments were well tolerated.Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.

View Article: PubMed Central - PubMed

Affiliation: Hôpital Lapeyronie, Service de Nephrologie, Montpellier, France. b-canaud@chu-montpellier.fr

ABSTRACT

Background: Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life ( approximately 130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis.

Methods: STRIATA (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment for Anaemia) was a multicentre, open-label randomized phase III study to evaluate the efficacy and safety of intravenous C.E.R.A. administered once every 2 weeks (Q2W) for Hb maintenance following direct conversion from darbepoetin alfa (DA). Adult patients on dialysis receiving stable intravenous DA once weekly (QW) or Q2W were randomized (1:1) to continue their current DA regimen (n = 156) or receive intravenous C.E.R.A. Q2W (n = 157) for 52 weeks. Doses were adjusted to maintain Hb levels within +/- 1.0 g/dl of baseline and between 10.0 and 13.5 g/dl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 29-36).

Results: Most patients (>80%) received DA QW before randomization. The mean (95% CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 g/dl (-0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. Both treatments were well tolerated.

Conclusions: Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.

Show MeSH
Related in: MedlinePlus