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Beneficial dose conversion after switching from higher doses of shorter-acting erythropoiesis-stimulating agents to C.E.R.A in CKD patients in clinical practice: MINERVA Study

  • Nephrology - Original Paper
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Abstract

Purpose

To assess whether the correction dose recommended by the summary of product characteristics was adequate and to confirm the adequacy of the recommended conversion dosing strategies from shorter-acting erythropoiesis-stimulating agents (ESAs) to continuous erythropoietin receptor activator (C.E.R.A) in anaemic chronic kidney disease (CKD) patients in the clinical setting.

Methods

This was a 12-month, multicenter, prospective, observational study in anaemic CKD patients on haemodialysis and not on dialysis receiving C.E.R.A (at least one dose).

Results

A total of 227 patients were included (not on dialysis; n = 142; haemodialysis: n = 85). The present analysis was conducted on ESA-naïve patients (not on dialysis: n = 31) and patients switched from other ESA (not on dialysis: n = 63; haemodialysis: n = 57). Both on and not on dialysis patients switched from other ESA received lower starting C.E.R.A doses than those recommended, and remained stable during the 12-month period. The higher the previous ESA dose was, the more beneficial the C.E.R.A dose conversion factor was. The proportion of patients with stable haemoglobin within the target range (11–13 g/dL) did not vary during the 12-month period both in nondialysis CKD patients and in those undergoing dialysis [baseline: 42 (66.7 %) and 34 (59.6 %); month 6: 21 (55.3 %) and 26 (50.0 %); month 12: 20 (64.5 %) and 25 (69.4 %), respectively]. In naïve patients, the mean weight-adjusted C.E.R.A dose during the study (1.19 ± 0.49 µg/kg/month) was similar to the recommended one. C.E.R.A was well tolerated.

Conclusions

Conversion from shorter-acting ESAs to C.E.R.A doses lower than those recommended can efficiently maintain target haemoglobin levels both in nondialysis and haemodialysis CKD patients, particularly when switching from higher ESA doses. A monthly C.E.R.A dose of 1.2 µg/Kg seems adequate for anaemia correction.

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Acknowledgments

The authors would like to acknowledge the investigators of the MINERVA Study and the patients participating in the study. We also want to thank Roche Farma for supporting the study and the invaluable help of Beatriz Cuellar. Editorial and medical writing assistance was provided by Cristina Vidal and Antonio Torres from Dynamic. This study was sponsored by Roche Farma S.A., Spain, by an unrestricted grant to the Spanish Society of Nephrology. Roche Farma S.A had no role in the design of the study, in the accrual or analysis of the data, or in the preparation of the manuscript.

Conflict of interest

Dr. Cases has received research support from Amgen and Roche. He has also received honoraria for participating in advisory boards from Roche, Amgen, Pfizer, Novartis, Astra-Zeneca, Abbie, and speaker´s fees from Roche, Amgen, Johnson and Johnson, Bristol Myers Squibb, Novartis, Pfizer, Almirall, Zambon, and Siemens. Dr. Portoles has received speaker´s fees from Roche, Amgen, Johnson and Johnson and Abbvie. Dr, Martinez-Castelao has been consultant for Amgen, Abbott, Roche and Esteve and has received honoraria for lectures from Novartis, Boehringer Ingelheim and Lilly. The remaining of the authors declares that they do not have any conflict of interest.

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Authors and Affiliations

  1. Servicio de Nefrología, Hospital Clínic, Universitat de Barcelona, Villarroel 170, 08036, Barcelona, Spain

    Aleix Cases

  2. H. U. Puerta de Hierro, Majadahonda, Madrid, Spain

    José Portolés

  3. H. de Manacor, Majorca, Spain

    Jordi Calls

  4. H. de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain

    Alberto Martinez-Castelao

  5. H. Son Dureta, Majorca, Spain

    María Antonia Munar

  6. H. Vall d’Hebron, Barcelona, Spain

    Alfonso Segarra

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  1. Aleix Cases
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  2. José Portolés
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  3. Jordi Calls
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  4. Alberto Martinez-Castelao
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  5. María Antonia Munar
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  6. Alfonso Segarra
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Correspondence to Aleix Cases.

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On behalf of the MINERVA Study Investigators.

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Cases, A., Portolés, J., Calls, J. et al. Beneficial dose conversion after switching from higher doses of shorter-acting erythropoiesis-stimulating agents to C.E.R.A in CKD patients in clinical practice: MINERVA Study. Int Urol Nephrol 46, 1983–1995 (2014). https://doi.org/10.1007/s11255-014-0800-4

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