Evaluating extended-release calcifediol as a treatment option for chronic kidney disease-mineral and bone disorder (CKD-MBD)

References

• Levin A, Tonelli M, Bonventre J, et al. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet. 2017;390(10105):1888−1917.
   PubMed Web of Science ®Google Scholar
• Kidney Disease: improving Global Outcomes CKD-MBD Working Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl. 2009;113:S1−130.
   Google Scholar
• Moe S, Drueke T, Cunningham J, et al. Definition, evaluation, and classification of renal osteodystrophy: a position statement from kidney disease: improving global outcomes (KDIGO). Kidney Int. 2006;69(11):1945−1953.
   PubMed Web of Science ®Google Scholar
• Cunningham J, Locatelli F, Rodriguez M. Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options. Clin J Am Soc Nephrol. 2011;6(4):913−921.
   PubMed Web of Science ®Google Scholar
• Levin A, Bakris GL, Molitch M, et al. Prevalence of abnormal serum vitamin D, PTH, calcium, and phosphorus in patients with chronic kidney disease: results of the study to evaluate early kidney disease. Kidney Int. 2007;71(1):31−38.
   PubMed Web of Science ®Google Scholar
• Nigwekar SU, Tamez H, Thadhani RI. Vitamin D and chronic kidney disease-mineral bone disease (CKD-MBD). Bonekey Rep. 2014;3:498.
   PubMedGoogle Scholar
• Lishmanov A, Dorairajan S, Pak Y, et al. Elevated serum parathyroid hormone is a cardiovascular risk factor in moderate chronic kidney disease. Int Urol Nephrol. 2012;44(2):541−547.
   PubMed Web of Science ®Google Scholar
• Rodriguez M, Nemeth E, Martin D. The calcium-sensing receptor: a key factor in the pathogenesis of secondary hyperparathyroidism. Am J Physiol Renal Physiol. 2005;288(2):F253−264.
   PubMed Web of Science ®Google Scholar
• Holick MF. Vitamin D deficiency. N Engl J Med. 2007;357(3):266–281.
   PubMed Web of Science ®Google Scholar
• Jean G, Souberbielle JC, Chazot C. Vitamin D in chronic kidney disease and dialysis patients. Nutrients. 2017;9:4.
   Web of Science ®Google Scholar
• Koenig KG, Lindberg JS, Zerwekh JE, et al. Free and total 1,25-dihydroxyvitamin D levels in subjects with renal disease. Kidney Int. 1992;41(1):161−165.
   PubMed Web of Science ®Google Scholar
• Melamed ML, Thadhani RI. Vitamin D therapy in chronic kidney disease and end stage renal disease. Clin J Am Soc Nephrol. 2012;7(2):358−365.
   PubMed Web of Science ®Google Scholar
• Michaud J, Naud J, Ouimet D, et al. Reduced hepatic synthesis of calcidiol in uremia. J Am Soc Nephrol. 2010;21(9):1488−1497.
   PubMed Web of Science ®Google Scholar
• Petkovich M, Jones G. CYP24A1 and kidney disease. Curr Opin Nephrol Hypertens. 2011;20(4):337−344.
   PubMed Web of Science ®Google Scholar
• Cozzolino M, Ketteler M, Zehnder D. The vitamin D system: a crosstalk between the heart and kidney. Eur J Heart Fail. 2010;12(10):1031−1041.
   PubMed Web of Science ®Google Scholar
• Melamed ML, Chonchol M, Gutierrez OM, et al. The role of vitamin D in CKD stages 3 to 4: report of a scientific workshop sponsored by the national kidney foundation. Am J Kidney Dis. 2018;72(6):834−845.
   PubMed Web of Science ®Google Scholar
• Holick MF, Binkley NC, Bischoff-Ferrari HA, et al. Evaluation, treatment, and prevention of vitamin D deficiency: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(7):1911–1930.
   PubMed Web of Science ®Google Scholar
• Galassi A, Bellasi A, Ciceri P, et al. Calcifediol to treat secondary hyperparathyroidism in patients with chronic kidney disease. Expert Rev Clin Pharmacol. 2017;10(10):1073–1084.
   PubMed Web of Science ®Google Scholar
• Dusso AS, Brown AJ, Slatopolsky E. Vitamin D. Am J Physiol Renal Physiol. 2005;289(1):F8–28.
   PubMed Web of Science ®Google Scholar
• National Kidney F. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(4 Suppl 3):S1–201.
   PubMed Web of Science ®Google Scholar
• Ross AC, Taylor CL, Yaktine AL, et al. eds. Dietary reference intakes for calcium and vitamin D. Washington (DC): The National Academies Collection: reports funded by National Institutes of Health; 2011. DOI:10.17226/13050
   Google Scholar
• Ennis JL, Worcester EM, Coe FL, et al. Current recommended 25-hydroxyvitamin D targets for chronic kidney disease management may be too low. J Nephrol. 2016;29(1):63−70.
   PubMed Web of Science ®Google Scholar
• Strugnell SA, Sprague SM, Ashfaq A, et al. Rationale for raising current clinical practice guideline target for serum 25-Hydroxyvitamin D in chronic kidney disease. Am J Nephrol. 2019;49(4):284−293.
   PubMed Web of Science ®Google Scholar
• Bellasi A, Galassi A, Mangano M, et al. Vitamin D metabolism and potential effects of vitamin D receptor modulation in chronic kidney disease. Curr Drug Metab. 2017;18(7):680−688.
   PubMed Web of Science ®Google Scholar
• Ritter CS, Haughey BH, Armbrecht HJ, et al. Distribution and regulation of the 25-hydroxyvitamin D3 1alpha-hydroxylase in human parathyroid glands. J Steroid Biochem Mol Biol. 2012;130(1–2):73−80.
   PubMed Web of Science ®Google Scholar
• Dusso AS, Kamimura S, Gallieni M, et al. gamma-Interferon-induced resistance to 1,25-(OH)2 D3 in human monocytes and macrophages: a mechanism for the hypercalcemia of various granulomatoses. J Clin Endocrinol Metab. 1997;82:2222−2232.
   PubMed Web of Science ®Google Scholar
• Zehnder D, Bland R, Williams MC, et al. Extrarenal expression of 25-hydroxyvitamin d(3)-1 alpha-hydroxylase. J Clin Endocrinol Metab. 2001;86:888−894.
   PubMed Web of Science ®Google Scholar
• Nishimura M, Yaguti H, Yoshitsugu H, et al. Tissue distribution of mRNA expression of human cytochrome P450 isoforms assessed by high-sensitivity real-time reverse transcription PCR. Yakugaku Zasshi. 2003;123:369−75.
   PubMed Web of Science ®Google Scholar
• Bikle DD, Chang S, Crumrine D, et al. 25 Hydroxyvitamin D 1 alpha-hydroxylase is required for optimal epidermal differentiation and permeability barrier homeostasis. J Invest Dermatol. 2004;122:984−92.
   PubMed Web of Science ®Google Scholar
• Evans KN, Taylor H, Zehnder D, et al. Increased expression of 25-hydroxyvitamin D-1alpha-hydroxylase in dysgerminomas: a novel form of humoral hypercalcemia of malignancy. Am J Pathol. 2004;165:807–813.
   PubMed Web of Science ®Google Scholar
• Dusso A, Lopez-Hilker S, Rapp N, et al. Extra-renal production of calcitriol in chronic renal failure. Kidney Int. 1988;34(3):368−375.
   PubMed Web of Science ®Google Scholar
• Vantavo (alendronic acid 70 mg/colecalciferol 70 µg) Summary of product characteristics. [cited 2019 May]. Available from: https://ec.europa.eu/health/documents/community-register/2011/20110629104250/anx_104250_en.pdf
   Google Scholar
• Calcichew-D3 (Calcium carbonate 1250 mg/Colecalciferol 400 IU) summary of product characteristics. [cited 2019 May]. Available from: https://www.medicines.org.uk/emc/product/5229/smpc
   Google Scholar
• Colecalciferol 20 000 IU Capsules. Summary of product characteristics. [cited 2019 May]. Available from: https://www.medicines.org.uk/emc/product/7147/smpc
   Google Scholar
• Ergocalciferol Injection BP 300,000U. Summary of product characteristics. [cited 2019.May]. Available from: https://www.medicines.org.uk/emc/product/9133/smpc
   Google Scholar
• British National Formulary. Ergocalciferol prescribing and technical information. [cited 2019 May]. Available from: https://bnf.nice.org.uk/drug/ergocalciferol.html
   Google Scholar
• Immediate release calcifediol (Dedrogyl/Hidroferol). Prescribing Information. [cited 2019 Jun]. Available from: http://drugspi.org/Calcifediol
   Google Scholar
• RAYALDEE (calcifediol) extended-release capsules. Prescribing Information. [cited 2019 May]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208010s000lbl.pdf
   Google Scholar
• Rocaltrol (calcitriol) capsules. Summary of product characteristics. [cited 2019 May]. Available from: https://www.medicines.org.uk/emc/product/1115/smpc
   Google Scholar
• Zemplar (paricalcitol) soft capsules. Summary of product characteristics. [cited 2019 May]. Available from https://www.medicines.org.uk/emc/product/6166/smpc
   Google Scholar
• Zemplar (paricalcitol) solution for injection. Summary of product characteristics. [cited 2019 May]. Available from: https://www.medicines.org.uk/emc/product/3931/smpc
   Google Scholar
• Hectorol (doxercalciferol) prescribing information. [cited 2019 May]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021027s015lbl.pdf
   Google Scholar
• One-Alpha Injection (alfacalcidol 2 micrograms/ml). Summary of product characteristics. [cited 2019 May]. Available from: https://www.medicines.org.uk/emc/product/984/smpc
   Google Scholar
• Mimpara (cinacalcet) film-coated tablets. Summary of product characteristics. [cited 2019 May]. Available from: https://www.ema.europa.eu/en/documents/product-information/mimpara-epar-product-information_en.pdf
   Google Scholar
• Parsabiv (etelcalcetide) solution for injection. Summary of product characteristics. [cited 2019 May]. Available from: https://www.ema.europa.eu/en/documents/product-information/parsabiv-epar-product-information_en.pdf
   Google Scholar
• Kyowa Hakko Kirin Co., Ltd. Press release: kyowa Hakko Kirin launches ORKEDIA® TABLETS (Evocalcet) for the treatment of secondary hyperparathyroidism in patients on maintenance dialysis in Japan. [updated 2019 May 2018;cited 2019 Jul]. Available from: https://www.kyowakirin.com/media_center/news_releases/2018/pdf/e20180522_01.pdf
   Google Scholar
• Eidman KE, Wetmore JB. Treatment of secondary hyperparathyroidism: how do cinacalcet and etelcalcetide differ? Semin Dial. 2018;31(5):44−444.
   Web of Science ®Google Scholar
• Miyazaki H, Ikeda Y, Sakurai O, et al. Discovery of evocalcet, a next-generation calcium-sensing receptor agonist for the treatment of hyperparathyroidism. Bioorg Med Chem Lett. 2018;28:2055−2060.
   PubMed Web of Science ®Google Scholar
• Agarwal R, Georgianos PI. Con: nutritional vitamin D replacement in chronic kidney disease and end-stage renal disease. Nephrol Dial Transplant. 2016;31(5):706−713.
   PubMed Web of Science ®Google Scholar
• Bordier PJ, Marie PJ, Arnaud CD. Evolution of renal osteodystrophy: correlation of bone histomorphometry and serum mineral and immunoreactive parathyroid hormone values before and after treatment with calcium carbonate or 25-hydroxycholecalciferol. Kidney Int Suppl. 1975;2:102−112.
   PubMedGoogle Scholar
• Fournier A, Idrissi A, Sebert JL, et al. Preventing renal bone disease in moderate renal failure with CaCO3 and 25(OH) vitamin D3. Kidney Int Suppl. 1988;24:S178−179.
   PubMedGoogle Scholar
• Li XH, Feng L, Yang ZH, et al. Effect of active vitamin D on cardiovascular outcomes in predialysis chronic kidney diseases: a systematic review and meta-analysis. Nephrology (Carlton). 2015;20(10):706−714.
   PubMed Web of Science ®Google Scholar
• Thadhani R, Appelbaum E, Pritchett Y, et al. Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial. JAMA. 2012;307(7):674−684.
   PubMed Web of Science ®Google Scholar
• Wang AY, Fang F, Chan J, et al. Effect of paricalcitol on left ventricular mass and function in CKD–the OPERA trial. J Am Soc Nephrol. 2014;25(1):175−186.
   PubMed Web of Science ®Google Scholar
• Kidney Disease: improving Global Outcomes CKD-MBD Working Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, Prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl. 2017;7(1):1−59.
   Web of Science ®Google Scholar
• Cozzolino M, Brancaccio D. Emerging role for the vitamin D receptor activator (VDRA), paricalcitol, in the treatment of secondary hyperparathyroidism. Expert Opin Pharmacother. 2008;9(6):947−954.
   PubMed Web of Science ®Google Scholar
• Goldsmith DJ. Pro: should we correct vitamin D deficiency/insufficiency in chronic kidney disease patients with inactive forms of vitamin D or just treat them with active vitamin D forms? Nephrol Dial Transplant. 2016;31(5):698−705.
   PubMed Web of Science ®Google Scholar
• Sprague SM, Crawford PW, Melnick JZ, et al. Use of extended-release calcifediol to treat secondary hyperparathyroidism in stages 3 and 4 chronic kidney disease. Am J Nephrol. 2016;44(4):316−325.
   PubMed Web of Science ®Google Scholar
• Sprague SM, Strugnell SA, Bishop CW. Extended-release calcifediol for secondary hyperparathyroidism in stage 3-4 chronic kidney disease. Expert Rev Endocrinol Metab. 2017;12(5):289−301.
   PubMed Web of Science ®Google Scholar
• Chonchol M, Locatelli F, Abboud HE, et al. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet HCl in participants with CKD not receiving dialysis. Am J Kidney Dis. 2009;53(2):197−207.
   PubMed Web of Science ®Google Scholar
• Montenegro J, Cornago I, Gallardo I, et al. Efficacy and safety of cinacalcet for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney disease before initiation of regular dialysis. Nephrology (Carlton). 2012;17(1):26−31.
   PubMed Web of Science ®Google Scholar
• Petkovich M, Melnick J, White J, et al. Modified-release oral calcifediol corrects vitamin D insufficiency with minimal CYP24A1 upregulation. J Steroid Biochem Mol Biol. 2015;148:283–289.
   PubMed Web of Science ®Google Scholar
• Sprague SM, Silva AL, Al-Saghir F, et al. Modified-release calcifediol effectively controls secondary hyperparathyroidism associated with vitamin D insufficiency in chronic kidney disease. Am J Nephrol. 2014;40(6):535–545.
   PubMed Web of Science ®Google Scholar
• Kopyt NA, Strugnell SA, Ashfaq A, et al. Effect of baseline serum calcium on responses to extended-release calcifediol (ERC) in stage 3-4 CKD. J Am Soc Nephrol. 2017;28:232. Poster presented at American Society of Nephrology Annual Meeting 2017 (Abstract # TH-PO513).
   Google Scholar
• Sprague SM, Strugnell SA, Ashfaq A, et al. PTH suppression with extended-release calcifediol (ERC) is directly proportional to severity of secondary hyperparathyroidism (SHPT). J Am Soc Nephrol. 2017;28:233. Poster presented at American Society of Nephrology Annual Meeting 2017 (Abstract #TH-PO515).
   Google Scholar