Vascular calcification, vitamin K, phosphate binders and MGP
- Conditions
- Vascular calcification, phosphate binders, chronic kidney disease, vitamin K, MGP
- Registration Number
- NL-OMON26614
- Lead Sponsor
- VUmc Amsterdam
- Brief Summary
1 Arterial media calcification in end stage renal disease: impact on all cause and cardiovascular mortality. London GM, Guerin AP, Marchais S.J, et al. Nephrol Dial Transplant. 2003 Sept; 18(9): 1731-40.<br> 2 Braun J, Oldenhof M, Moshage W, et al.Electron beam computed tomography in the evaluation of cardiac calcification in chronic dialysis patients. Am J Kidney Dis. 1996 Mar; 27(3): 294-401.<br> 3 Goodman W.G, Goldin J, Kuizon B.D, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med. 2000 May; 342 (20): 1478-83.<br> 4 Chertow GM, Burke SK, Raggi P. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002 jul; 62 (1): 245-52. 5 McCullough P.A, Sandberg K.R, Dumler F, Yanez J.E. Determinants of coronary vascular calcification in patients with chronic kidney disease and end-stage renal disease: a systematic review. J Nephrol. 2004 Mar-Apr; 17(2): 205-15.<br> 6 Moe SM, O’Neill KD, Reslerova M, et al. Natural history of vascular calcification in dialysis and transplant patients. Nephrol Dial Transplant. 2004; 19: 2387-93.<br> 7 Luo G,Ducy P, McKee MD, et al. Spontaneous calcification of arteries and cartilage in mice lacking matrix GLA protein.Nature 1997; 386: 78-81. <br> 8 Geleijnse JM, Vermeer C, Grobbee DE, et al. Dietary intake of menaquinone is associated with a reduced risk of coronary heart disease: the Rotterdam Study. J Nutr. 2004 Nov; 134(11): 3100-5. <br> 9 Furie, B, Bouchard, B, Furie, BC.Vitamin K-dependent biosynthesis of gamma-carboxyglutamic acid. Blood 1999; 93:1798. <br> 10 Davie, EW. Biochemical and molecular aspects of the coagulation cascade.ThrombHaemost 1995; 74:1. <br> 11 Francucci CM, Ceccoli L, Rilli S, et al. Skeletal effects of oral anticoagulants. J Endocrinol Invest.2009; 32(4 Suppl): 27-31. <br> 12 Schurgers LJ, Barreto DV, Barreto FC, et al. The circulating Inactive form of MGP is a surrogate marker for vascular calcification in chronic kidney disease: A preliminary report. J Am SocNephrol. 2010 Apr; 5(4): 568-75.<br> 13 Geleijnse JM, Vermeer C, Grobbee DE, et al. Dietary intake of menaquinone is associated with a reduced risk of coronary heart disease: the Rotterdam Study. J Nutr. 2004 Nov; 134(11): 3100-5.<br> 14 Krueger T, Westenfeld R, Ketteler M, Schurgers LJ, Floege J. Vitamin K deficiency in CKD patients, a modifiable risk factor for vascular calcification. Kidney International 2009; 76: 18–22. <br> 15 Westenfeld R, Krueger T, Schlieper G, et al. Effect of vitamin K2 supplementation on functional vitamin K deficiency in hemodialysis patients: a randomized trial. Am J Kidney Dis.2012 Feb; 59(2):186-95.<br> 16 Koos R, Mahnken AH, Muhlenbruch G, et al. Relation of oral anticoagulation to cardiac valvular and coronary calcium assessed by multislice spiral computed tomography. Am J Cardiol 2005; 96: 747-749.<br> 17 Takagi K, Masuda K, Yamazaki M, et al. Metal and ion and vitamin adsorption profiles of phosphate binder ion-exchange resins. Clin. Nephrol. 2010 Jan; 73(1): 30-5.<br> 18 Sevelamer Summary Product information.<br> 19 Pierce D, Hossack S, Poole L, et al.The effect of sevelamer carbonate and lanthanum carbonate on the pharmacokinetics of oral calcitriol.Nephrol. Dial. Transplant. 2011 May; 26(5): 1615-21.<br> 20 Block GA, Wheeler DC, Persky MS, et al. Effects of phosphate binders in moderate CKD. J. Am. Soc. Nephrol 2012 Aug; 23(8): 1407-15.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Haemodialysis patients aged 18 years or above without the prospect of renal function recovery, planned renal transplantation, and life expectancy longer than six months.
1 Use of vitamin K antagonists
2 Calcium under 2,1 mmol/l or above 2,6 mmol/l, after correction for albumin level
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute difference between serum level of dp-ucMGP and PIVKA II at week 8 between phosphate binder groups (between group analysis).
- Secondary Outcome Measures
Name Time Method Absolute change from baseline to end of treatment period for lanthanumcarbonate group and calciumcarbonate group, respectively (longitudinal within group analysis). Association between change in dp-ucMGP and PIVKA II. Change in dp-ucMGP between week 16 and 20.