The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia

Summary

Background: Patient with stage 3 or 4 chronic kidney disease (CKD) usually has normal level of serum phosphate, due to increased serum fibroblast growth factor-23 (FGF23) level that resulted in increased phosphate urine excretion. On the other hand, serum FGF23 elevation was related to CKD progression, vascular calcification, cardiomegaly, and mortality. This double blind, randomized controlled trial study was conducted to evaluate effectiveness and safety of calcium carbonate administration in stage 3 or 4 CKD patients with normophosphatemia. Hypothesis: Calcium carbonate administration is effective and safe in chronic kidney disease (CKD) with normophosphatemia.

Timeline

Start

2015-11-06

Primary completion

2016-12-11

Completion

2016-12-11

Publications

• Results Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease. JAMA. 2011 Jun 15;305(23):2432-9. doi: 10.1001/jama.2011.826.
• Results Martin K, Floege J, Ketteler M. Bone and mineral metabolism in chronic kidney disease. In: Johnson R, Feehally J, Floege J, editors. Comprehensive clinical nephrology. Fifth edition. Philadelphia: Saunders; 2015. p. 984-7.
• Results Ketteler M, Leonard M. KDIGO 2016 Clinical practice guideline update on diagnosis, evaluation, prevention, and treatment of CKD-MBD. Off J Int Soc Nephrol. 2016;(August):1-45
• Results Prakash S, O'Hare AM. Interaction of aging and chronic kidney disease. Semin Nephrol. 2009 Sep;29(5):497-503. doi: 10.1016/j.semnephrol.2009.06.006.
• Results Iseki K. Gender differences in chronic kidney disease. Kidney Int. 2008 Aug;74(4):415-7. doi: 10.1038/ki.2008.261.
• Results Perhimpunan Nefrologi Indonesia. 8th Report of Indonesian Renal Registry. Jakarta; 2015
• Results Bayliss G, Weinrauch LA, D'Elia JA. Pathophysiology of obesity-related renal dysfunction contributes to diabetic nephropathy. Curr Diab Rep. 2012 Aug;12(4):440-6. doi: 10.1007/s11892-012-0288-1.
• Results Langman CB, Cannata-Andia JB. Calcium in chronic kidney disease: myths and realities. Introduction. Clin J Am Soc Nephrol. 2010 Jan;5 Suppl 1:S1-2. doi: 10.2215/CJN.06140809. No abstract available.
• Results Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F; MMKD Study Group; Kuen E, Konig P, Kraatz G, Mann JF, Muller GA, Kohler H, Riegler P. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol. 2007 Sep;18(9):2600-8. doi: 10.1681/ASN.2006080936. Epub 2007 Jul 26.
• Results Soriano S, Ojeda R, Rodriguez M, Almaden Y, Rodriguez M, Martin-Malo A, Aljama P. The effect of phosphate binders, calcium and lanthanum carbonate on FGF23 levels in chronic kidney disease patients. Clin Nephrol. 2013 Jul;80(1):17-22. doi: 10.5414/CN107764.
• Results Shigematsu T, Negi S; COLC Research Group. Combined therapy with lanthanum carbonate and calcium carbonate for hyperphosphatemia decreases serum FGF-23 level independently of calcium and PTH (COLC Study). Nephrol Dial Transplant. 2012 Mar;27(3):1050-4. doi: 10.1093/ndt/gfr388. Epub 2011 Jul 19.
• Results Oliveira RB, Cancela AL, Graciolli FG, Dos Reis LM, Draibe SA, Cuppari L, Carvalho AB, Jorgetti V, Canziani ME, Moyses RM. Early control of PTH and FGF23 in normophosphatemic CKD patients: a new target in CKD-MBD therapy? Clin J Am Soc Nephrol. 2010 Feb;5(2):286-91. doi: 10.2215/CJN.05420709. Epub 2009 Nov 12.
• Results Block GA, Wheeler DC, Persky MS, Kestenbaum B, Ketteler M, Spiegel DM, Allison MA, Asplin J, Smits G, Hoofnagle AN, Kooienga L, Thadhani R, Mannstadt M, Wolf M, Chertow GM. Effects of phosphate binders in moderate CKD. J Am Soc Nephrol. 2012 Aug;23(8):1407-15. doi: 10.1681/ASN.2012030223. Epub 2012 Jul 19.
• Results Sprague SM, Abboud H, Qiu P, Dauphin M, Zhang P, Finn W. Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial. Clin J Am Soc Nephrol. 2009 Jan;4(1):178-85. doi: 10.2215/CJN.02830608. Epub 2008 Dec 3.
• Results Hill KM, Martin BR, Wastney ME, McCabe GP, Moe SM, Weaver CM, Peacock M. Oral calcium carbonate affects calcium but not phosphorus balance in stage 3-4 chronic kidney disease. Kidney Int. 2013 May;83(5):959-66. doi: 10.1038/ki.2012.403. Epub 2012 Dec 19.

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Indications