Abstract
Background
Knowledge about mineral bone disorder (MBD) management in non-dialysis chronic kidney disease (ND-CKD) patients is scarce, although essential to identifying areas for therapeutic improvement.
Methods
We prospectively evaluated current management of CKD-MBD in two visits, performed 6 months apart, in 727 prevalent ND-CKD stage 3b–5 patients from 19 nephrology clinics. Therapeutic inertia was defined as lack of treatment despite hyperphosphatemia and/or hypocalcemia, and/or hyperparathyroidism. The primary endpoint was the prevalence of achieved target for CKD-MBD parameters and related treatments (phosphate binders, vitamin D and calcium supplements). The secondary endpoint was the assessment of prevalence and clinical correlates of therapeutic inertia.
Results
Over 65 % of patients did not reach parathormone (PTH) targets, while 15 and 19 % did not reach phosphate and calcium targets, respectively. The proportion of untreated patients decreased from stage 3b to 5 (at baseline, from 60 to 16 %, respectively). From baseline to the 6-month visit, the achievement of targets remained stable. Low protein diet was prescribed in 26 % of patients, phosphate binders in 17.3 % (calcium-based binders 15.5 %, aluminium binders 1.8 %), and vitamin D in 50.5 %. The overall prevalence of therapeutic inertia at the 6-month visit was 34.0 % (for hyperphosphatemia, 54.3 %). Compared to CKD stage 3, the likelihood of therapeutic inertia was 40 and 68 % lower at stage 4 and 5, respectively.
Conclusions
PTH, calcium and phosphate targets were not reached in a significant proportion of patients. One-third of patients with at least one MBD parameter not-at-target remained untreated. Therapeutic inertia regarding CKD-MBD treatment may be a major barrier to optimizing the prevention and cure of CKD-MBD.
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Acknowledgments
This study was designed by the Treatment of CKD Study Group of Italian Society of Nephrology. This study was funded by an unrestricted grant provided by Roche to the Italian Society of Nephrology.
Conflict of interest
The authors declare that they have no conflict of interest related to this research.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent
The study protocol was approved by the ethical committee of each participating center and patients were enrolled after signing informed consent.
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For the REport of COmorbidities in non-dialysis Renal Disease population in ITaly (RECORD-IT) Study Group.
The complete list of authors is reported in the “Appendix”.
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Appendix: Complete list of investigators
Appendix: Complete list of investigators
A. Dal Canton, P. Esposito (University of Pavia. Pavia), M. Formica, M. Tamagnone (Savigliano and Ceva Hospitals, Cuneo), G. Segoloni, L. Colla (University of Torino, Torino), M. Gallieni (S. Carlo Borromeo Hospital, Milano), F. Locatelli, M.M. Corti (A. Manzoni Hospital, Lecco), R. Tarchini, C.D. Marseglia (C. Poma Hospital, Mantova), G. Meneghel, A. Nardelotto (Dolo General Hospital, Dolo), L. Oldrizzi, V. Cosentini (Fracastoro Hospital, San Bonifacio), M. Cossu (SS Annunziata Hospital, Sassari), S. Di Giulio, M. Beraldi (S. Camillo Forlanini Hospital, Roma), M. Malaguti (S. Paolo Hospital, Civitavecchia), F. Pizzarelli, P. Dattolo (S. M. Annunziata, Firenze), G. Quintaliani, Claudia Savignani (S. Maria della Misericordia Hospital, Perugia), B. Cianciaruso, A. Pisani (University “Federico II”, Naples), G. Conte, N. De Luca, R. Minutolo, M. Pacilio (Second University of Naples, Naples), R. Bonofiglio (Ospedale dell’Annunziata, Cosenza), G. Fuiano, P. Cianfrone (University of Catanzaro, Catanzaro), G. Grandaliano (University of Foggia, Foggia), G. Bellinghieri, D. Santoro (University of Messina, Messina).
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Gallieni, M., De Luca, N., Santoro, D. et al. Management of CKD-MBD in non-dialysis patients under regular nephrology care: a prospective multicenter study. J Nephrol 29, 71–78 (2016). https://doi.org/10.1007/s40620-015-0202-4
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DOI: https://doi.org/10.1007/s40620-015-0202-4