C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis

Results of a randomized clinical trial

Iain C. Macdougall, Rowan Walker, Robert Provenzano, Fernando de Alvaro, Harold R. Locay, Paul C. Nader, Francesco Locatelli, Frank C. Dougherty, Ulrich Beyer, P. Altieri, M. Amato, M. Annerstedt, A. Balducci, P. Barre, C. Breen, E. Brown, R. Burgos-Calderon, G. Carpenito, G. Choukroun, L. Craver & 71 others B. Culleton, F. de Alvaro, G. Deferrari, M. del Pino y Pino, G. P. Dragoun, D. Durand, V. Esnault, P. Evenepoel, B. Faller, A. Fine, D. Fischer, M. Formica, U. Frei, L. Frenken, T. Golper, C. Hagen, K. Hahn, K. Harris, E. Imbasciati, C. Jacquot, S. Jolly, G. Kaysen, P. Kerr, M. Kessler, N. Kopyt, C. Kovesdy, J. Kraut, J. Kwan, R. Lafayette, M. Laville, A. Levin, F. Locatelli, H. R. Locay, C. Lok, I. C. Macdougall, I. MacPhee, J. E Marco Franco, A. Martinez Castelao, A. McMahon, E. Morales Ruiz, N. Muirhead, S. Murphy, P. C. Nader, G. M. Nassar, S. Noble, G. Papadakis, I. Papadakis, J. Penfield, V. Pichette, R. Provenzano, G. Pylypchuk, T. Risler, D. Rodriguez Puyol, S. Rosansky, G. Sakellariou, R. Schmidt, K. Siamopoulos, R. Solomon, B. Spinowitz, B. Stegmayr, M. Suranyi, P. Tam, S. Tobe, V. Vargemezis, C. Vela, G. Villa, R. Walker, K. Warr, C. Wijeyesinghe, R. Woitas, C. Zoccali

Research output: Contribution to journalArticle

93 Citations (Scopus)

Abstract

Background and objectives: This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis. Design, setting, participants, & measurements: In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb ±1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation. Results: Hb response rates were 97.5% for C.E.R.A. and 96.3% for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated. Conclusions: Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA-naïve patients who are not on dialysis.

Original languageEnglish (US)
Pages (from-to)337-347
Number of pages11
JournalClinical Journal of the American Society of Nephrology
Volume3
Issue number2
DOIs
StatePublished - Mar 2008

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Chronic Renal Insufficiency
Anemia
Dialysis
Hemoglobins
Randomized Controlled Trials
Hematinics
Darbepoetin alfa

ASJC Scopus subject areas

  • Nephrology
  • Transplantation
  • Epidemiology
  • Critical Care and Intensive Care Medicine

Cite this

C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis : Results of a randomized clinical trial. / Macdougall, Iain C.; Walker, Rowan; Provenzano, Robert; de Alvaro, Fernando; Locay, Harold R.; Nader, Paul C.; Locatelli, Francesco; Dougherty, Frank C.; Beyer, Ulrich; Altieri, P.; Amato, M.; Annerstedt, M.; Balducci, A.; Barre, P.; Breen, C.; Brown, E.; Burgos-Calderon, R.; Carpenito, G.; Choukroun, G.; Craver, L.; Culleton, B.; de Alvaro, F.; Deferrari, G.; del Pino y Pino, M.; Dragoun, G. P.; Durand, D.; Esnault, V.; Evenepoel, P.; Faller, B.; Fine, A.; Fischer, D.; Formica, M.; Frei, U.; Frenken, L.; Golper, T.; Hagen, C.; Hahn, K.; Harris, K.; Imbasciati, E.; Jacquot, C.; Jolly, S.; Kaysen, G.; Kerr, P.; Kessler, M.; Kopyt, N.; Kovesdy, C.; Kraut, J.; Kwan, J.; Lafayette, R.; Laville, M.; Levin, A.; Locatelli, F.; Locay, H. R.; Lok, C.; Macdougall, I. C.; MacPhee, I.; Franco, J. E Marco; Castelao, A. Martinez; McMahon, A.; Ruiz, E. Morales; Muirhead, N.; Murphy, S.; Nader, P. C.; Nassar, G. M.; Noble, S.; Papadakis, G.; Papadakis, I.; Penfield, J.; Pichette, V.; Provenzano, R.; Pylypchuk, G.; Risler, T.; Puyol, D. Rodriguez; Rosansky, S.; Sakellariou, G.; Schmidt, R.; Siamopoulos, K.; Solomon, R.; Spinowitz, B.; Stegmayr, B.; Suranyi, M.; Tam, P.; Tobe, S.; Vargemezis, V.; Vela, C.; Villa, G.; Walker, R.; Warr, K.; Wijeyesinghe, C.; Woitas, R.; Zoccali, C.

In: Clinical Journal of the American Society of Nephrology, Vol. 3, No. 2, 03.2008, p. 337-347.

Research output: Contribution to journalArticle

Macdougall, IC, Walker, R, Provenzano, R, de Alvaro, F, Locay, HR, Nader, PC, Locatelli, F, Dougherty, FC, Beyer, U, Altieri, P, Amato, M, Annerstedt, M, Balducci, A, Barre, P, Breen, C, Brown, E, Burgos-Calderon, R, Carpenito, G, Choukroun, G, Craver, L, Culleton, B, de Alvaro, F, Deferrari, G, del Pino y Pino, M, Dragoun, GP, Durand, D, Esnault, V, Evenepoel, P, Faller, B, Fine, A, Fischer, D, Formica, M, Frei, U, Frenken, L, Golper, T, Hagen, C, Hahn, K, Harris, K, Imbasciati, E, Jacquot, C, Jolly, S, Kaysen, G, Kerr, P, Kessler, M, Kopyt, N, Kovesdy, C, Kraut, J, Kwan, J, Lafayette, R, Laville, M, Levin, A, Locatelli, F, Locay, HR, Lok, C, Macdougall, IC, MacPhee, I, Franco, JEM, Castelao, AM, McMahon, A, Ruiz, EM, Muirhead, N, Murphy, S, Nader, PC, Nassar, GM, Noble, S, Papadakis, G, Papadakis, I, Penfield, J, Pichette, V, Provenzano, R, Pylypchuk, G, Risler, T, Puyol, DR, Rosansky, S, Sakellariou, G, Schmidt, R, Siamopoulos, K, Solomon, R, Spinowitz, B, Stegmayr, B, Suranyi, M, Tam, P, Tobe, S, Vargemezis, V, Vela, C, Villa, G, Walker, R, Warr, K, Wijeyesinghe, C, Woitas, R & Zoccali, C 2008, 'C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: Results of a randomized clinical trial', Clinical Journal of the American Society of Nephrology, vol. 3, no. 2, pp. 337-347. https://doi.org/10.2215/CJN.00480107
Macdougall, Iain C. ; Walker, Rowan ; Provenzano, Robert ; de Alvaro, Fernando ; Locay, Harold R. ; Nader, Paul C. ; Locatelli, Francesco ; Dougherty, Frank C. ; Beyer, Ulrich ; Altieri, P. ; Amato, M. ; Annerstedt, M. ; Balducci, A. ; Barre, P. ; Breen, C. ; Brown, E. ; Burgos-Calderon, R. ; Carpenito, G. ; Choukroun, G. ; Craver, L. ; Culleton, B. ; de Alvaro, F. ; Deferrari, G. ; del Pino y Pino, M. ; Dragoun, G. P. ; Durand, D. ; Esnault, V. ; Evenepoel, P. ; Faller, B. ; Fine, A. ; Fischer, D. ; Formica, M. ; Frei, U. ; Frenken, L. ; Golper, T. ; Hagen, C. ; Hahn, K. ; Harris, K. ; Imbasciati, E. ; Jacquot, C. ; Jolly, S. ; Kaysen, G. ; Kerr, P. ; Kessler, M. ; Kopyt, N. ; Kovesdy, C. ; Kraut, J. ; Kwan, J. ; Lafayette, R. ; Laville, M. ; Levin, A. ; Locatelli, F. ; Locay, H. R. ; Lok, C. ; Macdougall, I. C. ; MacPhee, I. ; Franco, J. E Marco ; Castelao, A. Martinez ; McMahon, A. ; Ruiz, E. Morales ; Muirhead, N. ; Murphy, S. ; Nader, P. C. ; Nassar, G. M. ; Noble, S. ; Papadakis, G. ; Papadakis, I. ; Penfield, J. ; Pichette, V. ; Provenzano, R. ; Pylypchuk, G. ; Risler, T. ; Puyol, D. Rodriguez ; Rosansky, S. ; Sakellariou, G. ; Schmidt, R. ; Siamopoulos, K. ; Solomon, R. ; Spinowitz, B. ; Stegmayr, B. ; Suranyi, M. ; Tam, P. ; Tobe, S. ; Vargemezis, V. ; Vela, C. ; Villa, G. ; Walker, R. ; Warr, K. ; Wijeyesinghe, C. ; Woitas, R. ; Zoccali, C. / C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis : Results of a randomized clinical trial. In: Clinical Journal of the American Society of Nephrology. 2008 ; Vol. 3, No. 2. pp. 337-347.
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abstract = "Background and objectives: This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis. Design, setting, participants, & measurements: In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb ±1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation. Results: Hb response rates were 97.5{\%} for C.E.R.A. and 96.3{\%} for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated. Conclusions: Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA-na{\"i}ve patients who are not on dialysis.",
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language = "English (US)",
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TY - JOUR

T1 - C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis

T2 - Results of a randomized clinical trial

AU - Macdougall, Iain C.

AU - Walker, Rowan

AU - Provenzano, Robert

AU - de Alvaro, Fernando

AU - Locay, Harold R.

AU - Nader, Paul C.

AU - Locatelli, Francesco

AU - Dougherty, Frank C.

AU - Beyer, Ulrich

AU - Altieri, P.

AU - Amato, M.

AU - Annerstedt, M.

AU - Balducci, A.

AU - Barre, P.

AU - Breen, C.

AU - Brown, E.

AU - Burgos-Calderon, R.

AU - Carpenito, G.

AU - Choukroun, G.

AU - Craver, L.

AU - Culleton, B.

AU - de Alvaro, F.

AU - Deferrari, G.

AU - del Pino y Pino, M.

AU - Dragoun, G. P.

AU - Durand, D.

AU - Esnault, V.

AU - Evenepoel, P.

AU - Faller, B.

AU - Fine, A.

AU - Fischer, D.

AU - Formica, M.

AU - Frei, U.

AU - Frenken, L.

AU - Golper, T.

AU - Hagen, C.

AU - Hahn, K.

AU - Harris, K.

AU - Imbasciati, E.

AU - Jacquot, C.

AU - Jolly, S.

AU - Kaysen, G.

AU - Kerr, P.

AU - Kessler, M.

AU - Kopyt, N.

AU - Kovesdy, C.

AU - Kraut, J.

AU - Kwan, J.

AU - Lafayette, R.

AU - Laville, M.

AU - Levin, A.

AU - Locatelli, F.

AU - Locay, H. R.

AU - Lok, C.

AU - Macdougall, I. C.

AU - MacPhee, I.

AU - Franco, J. E Marco

AU - Castelao, A. Martinez

AU - McMahon, A.

AU - Ruiz, E. Morales

AU - Muirhead, N.

AU - Murphy, S.

AU - Nader, P. C.

AU - Nassar, G. M.

AU - Noble, S.

AU - Papadakis, G.

AU - Papadakis, I.

AU - Penfield, J.

AU - Pichette, V.

AU - Provenzano, R.

AU - Pylypchuk, G.

AU - Risler, T.

AU - Puyol, D. Rodriguez

AU - Rosansky, S.

AU - Sakellariou, G.

AU - Schmidt, R.

AU - Siamopoulos, K.

AU - Solomon, R.

AU - Spinowitz, B.

AU - Stegmayr, B.

AU - Suranyi, M.

AU - Tam, P.

AU - Tobe, S.

AU - Vargemezis, V.

AU - Vela, C.

AU - Villa, G.

AU - Walker, R.

AU - Warr, K.

AU - Wijeyesinghe, C.

AU - Woitas, R.

AU - Zoccali, C.

PY - 2008/3

Y1 - 2008/3

N2 - Background and objectives: This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis. Design, setting, participants, & measurements: In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb ±1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation. Results: Hb response rates were 97.5% for C.E.R.A. and 96.3% for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated. Conclusions: Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA-naïve patients who are not on dialysis.

AB - Background and objectives: This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis. Design, setting, participants, & measurements: In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb ±1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation. Results: Hb response rates were 97.5% for C.E.R.A. and 96.3% for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated. Conclusions: Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA-naïve patients who are not on dialysis.

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U2 - 10.2215/CJN.00480107

DO - 10.2215/CJN.00480107

M3 - Article

VL - 3

SP - 337

EP - 347

JO - Clinical Journal of the American Society of Nephrology

JF - Clinical Journal of the American Society of Nephrology

SN - 1555-9041

IS - 2

ER -