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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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Non-inferiority test for treatment differences. CI, confidence interval; ITT, intent-to-treat; PP, per-protocol; Hb, haemoglobin. P < 0.0001 for both comparisons.
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Figure 4: Non-inferiority test for treatment differences. CI, confidence interval; ITT, intent-to-treat; PP, per-protocol; Hb, haemoglobin. P < 0.0001 for both comparisons.

Mentions: Mean Hb levels during the evaluation period were similar between treatment groups (Table 3; Figure 3): 12.1 g/dl for C.E.R.A. and 11.8 g/dl for DA (Table 3). Adjusted mean changes in Hb between baseline and the evaluation period (PP population) were 0.06 g/dl for C.E.R.A. and −0.12 g/dl for DA with the mean (95% CI) difference between groups being 0.18 g/dl (−0.05, 0.41) (Figure 4). The lower limit of the 95% CI was considerably greater than the pre-defined −0.75 g/dl non-inferiority threshold, demonstrating that C.E.R.A. was non-inferior to DA for the maintenance of Hb levels (P < 0.0001). Comparable results were obtained when the test was repeated in the ITT population (Figure 4).


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)

Non-inferiority test for treatment differences. CI, confidence interval; ITT, intent-to-treat; PP, per-protocol; Hb, haemoglobin. P < 0.0001 for both comparisons.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

Figure 4: Non-inferiority test for treatment differences. CI, confidence interval; ITT, intent-to-treat; PP, per-protocol; Hb, haemoglobin. P < 0.0001 for both comparisons.
Mentions: Mean Hb levels during the evaluation period were similar between treatment groups (Table 3; Figure 3): 12.1 g/dl for C.E.R.A. and 11.8 g/dl for DA (Table 3). Adjusted mean changes in Hb between baseline and the evaluation period (PP population) were 0.06 g/dl for C.E.R.A. and −0.12 g/dl for DA with the mean (95% CI) difference between groups being 0.18 g/dl (−0.05, 0.41) (Figure 4). The lower limit of the 95% CI was considerably greater than the pre-defined −0.75 g/dl non-inferiority threshold, demonstrating that C.E.R.A. was non-inferior to DA for the maintenance of Hb levels (P < 0.0001). Comparable results were obtained when the test was repeated in the ITT population (Figure 4).

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