NDT Advance Access originally published online on February 29, 2008
Nephrology Dialysis Transplantation 2008 23(7):2311-2318; doi:10.1093/ndt/gfn026
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Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism
1 Denver Nephrologists, Denver, CO 2 Pines Clinical Research, Pembroke Pines, FL 3 St Francis Medical Center, Honolulu, HI 4 University of California, San Francisco, CA 5 Amgen Inc., Thousand Oaks, CA 6 University of Rochester Medical Center, Rochester, NY, USA
Correspondence and offprint requests to: Geoffrey A. Block, Denver Nephrologists, 130 Rampart Way Suite 300b, Denver, CO 80230, USA. Tel: +1-303-861-4845; Fax: +1-303-861-4842; E-mail: gablock{at}denverneph.net
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Abstract |
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Background. Adequate control of all four KDOQITM biochemical targets for chronic kidney disease, bone and mineral disorder (CKD-MBD), which include parathyroid hormone (PTH), calcium (Ca), phosphorus (P) and Ca x P, remains difficult and is accomplished in <6% of patients receiving haemodialysis. The objective of the current study was to determine whether treatment with cinacalcet combined with low doses of vitamin D sterols improves control of both PTH and Ca x P among haemodialysis patients with secondary hyperparathyroidism (sHPT).
Methods. This multicentre, open-label study enrolled haemodialysis subjects (N = 444) with moderate to severe sHPT (mean serum biPTH > 160–430 pg/mL) (
iPTH 300–800 pg/mL or ng/L). Cinacalcet was titrated sequentially (30–180 mg/day) during an 8-week dose-titration phase to achieve biPTH 
160 pg/mL (iPTH 300 pg/mL or ng/L) and efficacy was assessed over 8 weeks. At week 2 of the study, subjects receiving vitamin D sterols had doses reduced to the equivalent of 2 mcg of paricalcitol three times a week or 6 mcg/week. Among the efficacy endpoints were the proportion of subjects with mean biPTH 160 pg/mL (iPTH 300 pg/mL or ng/L), with mean Ca x P 55 mg2/dL2 (4.4 mmol2/L2) and with both simultaneously during the assessment phase.
Results. The majority of subjects (n = 375) reached the assessment phase of the study and were included in efficacy analyses; 39 subjects withdrew due to adverse events. Sixty-two percent of subjects achieved the biPTH target, 83% achieved the Ca x P target and 54% reached both targets. Treatment reduced biPTH by 35% (P < 0.0001), calcium by 11% (P < 0.0001), phosphorus by 7% (P < 0.0001) and Ca x P by 17% (P < 0.0001). The proportion of subjects with values for biPTH, for Ca x P and for both biPTH and Ca x P within the target range during the assessment phase did not differ between subjects who received cinacalcet together with vitamin D sterols, and those who received cinacalcet alone.
Conclusion. Among subjects with moderate to severe sHPT undergoing haemodialysis, combined therapy with cinacalcet and low doses of vitamin D sterols improved achievement of the biochemical targets for CKD-MBD recommended by the KDOQITM guidelines.
Keywords: cinacalcet; KDOQITM; PTH; secondary hyperparathyroidism; vitamin D
* The investigators are listed in the appendix.
Received for publication: 6. 4.07
Accepted in revised form: 15. 1.08
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