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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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Patient populations and disposition. †Non-safety reasons were kidney transplantation (C.E.R.A., n = 14; DA, n = 6), refusal of treatment (C.E.R.A., n = 4; DA, n = 3) and failure to return (C.E.R.A., n = 2). The remaining 11 patients (C.E.R.A., n = 6; DA, n = 5) withdrew for reasons that included patient vacation, patient decision, patient instability (poor medical condition), protocol violation, discontinuation of dialysis, enrolled in nocturnal haemodialysis study and starting home dialysis. DA, darbepoetin alfa; QW, once weekly; Q2W, once every 2 weeks; ITT, intent-to-treat; PP, perprotocol; AE, adverse event.
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Figure 2: Patient populations and disposition. †Non-safety reasons were kidney transplantation (C.E.R.A., n = 14; DA, n = 6), refusal of treatment (C.E.R.A., n = 4; DA, n = 3) and failure to return (C.E.R.A., n = 2). The remaining 11 patients (C.E.R.A., n = 6; DA, n = 5) withdrew for reasons that included patient vacation, patient decision, patient instability (poor medical condition), protocol violation, discontinuation of dialysis, enrolled in nocturnal haemodialysis study and starting home dialysis. DA, darbepoetin alfa; QW, once weekly; Q2W, once every 2 weeks; ITT, intent-to-treat; PP, perprotocol; AE, adverse event.

Mentions: Patients were recruited from 48 centres in 12 countries in Europe, Australia and Canada. The disposition of enrolled patients is shown in Figure 2. The ITT population comprised 313 patients who were randomized to C.E.R.A. Q2W (n = 157) or DA at their continued weekly dose and interval (n = 156). The PP population comprised 249 patients. The main reasons for exclusion from the PP population were less than five Hb values measured during evaluation (n = 37), inadequate iron status at baseline and during evaluation or no valid iron assessments (n = 29) and RBC transfusions within weeks 20–32 (n = 17). In addition, four patients in the C.E.R.A. group withdrew before receiving any study medication [protocol violation (n = 1), refused treatment (n = 1), failed to return (n = 2)] and were not included in the safety population.


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)

Patient populations and disposition. †Non-safety reasons were kidney transplantation (C.E.R.A., n = 14; DA, n = 6), refusal of treatment (C.E.R.A., n = 4; DA, n = 3) and failure to return (C.E.R.A., n = 2). The remaining 11 patients (C.E.R.A., n = 6; DA, n = 5) withdrew for reasons that included patient vacation, patient decision, patient instability (poor medical condition), protocol violation, discontinuation of dialysis, enrolled in nocturnal haemodialysis study and starting home dialysis. DA, darbepoetin alfa; QW, once weekly; Q2W, once every 2 weeks; ITT, intent-to-treat; PP, perprotocol; AE, adverse event.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

Figure 2: Patient populations and disposition. †Non-safety reasons were kidney transplantation (C.E.R.A., n = 14; DA, n = 6), refusal of treatment (C.E.R.A., n = 4; DA, n = 3) and failure to return (C.E.R.A., n = 2). The remaining 11 patients (C.E.R.A., n = 6; DA, n = 5) withdrew for reasons that included patient vacation, patient decision, patient instability (poor medical condition), protocol violation, discontinuation of dialysis, enrolled in nocturnal haemodialysis study and starting home dialysis. DA, darbepoetin alfa; QW, once weekly; Q2W, once every 2 weeks; ITT, intent-to-treat; PP, perprotocol; AE, adverse event.
Mentions: Patients were recruited from 48 centres in 12 countries in Europe, Australia and Canada. The disposition of enrolled patients is shown in Figure 2. The ITT population comprised 313 patients who were randomized to C.E.R.A. Q2W (n = 157) or DA at their continued weekly dose and interval (n = 156). The PP population comprised 249 patients. The main reasons for exclusion from the PP population were less than five Hb values measured during evaluation (n = 37), inadequate iron status at baseline and during evaluation or no valid iron assessments (n = 29) and RBC transfusions within weeks 20–32 (n = 17). In addition, four patients in the C.E.R.A. group withdrew before receiving any study medication [protocol violation (n = 1), refused treatment (n = 1), failed to return (n = 2)] and were not included in the safety population.

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