No registrations found.
ID
Source
Brief title
Health condition
Vascular calcification, phosphate binders, chronic kidney disease, vitamin K, MGP
Sponsors and support
Shire only study medication support, no financial support
Intervention
Outcome measures
Primary outcome
Absolute difference between serum level of dp-ucMGP and PIVKA II at week 8 between phosphate binder groups (between group analysis).
Secondary outcome
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.
Background summary
Vascular calcification (VC) is a problem in patients with chronic kidney disease especially in end stage kidney disease. VC is associated with increased mortality. In recent literature there is vascular calcification which progresses with use of phosphate binders. There are some small studies which have shown that phosphate binders can bind vitamin K as well. Vitamin K is necessary in the vessel wall to counteract VC. In this trial we are taking a better look at this interaction, because if phosphate binders bind vitamin K this can cause VC.
Study objective
This research will have as aim to look at progression or decrease in vascular calcification in dialysis population with use different phosphate binders. There is a possibility that different binders bind vitamin K in a different way in intestinal tract and thereby cause different level of calcification. Better insight in mechanisms of vascular calcification under circumstance can lead to therapeutic options which inhibit calcification and benefit survival of dialysis patients.
Study design
start: start with one of the phosphate binders
8 weeks: change of phosphate binder
16 weeks: start vitamin K2 supplemantation
20 weeks: end of trial
Intervention
treatment with calciumcarbonate or lanthanum carbonate with supplemantation of vitamin K
Inclusion criteria
Haemodialysis patients aged 18 years or above without the prospect of renal function recovery, planned renal transplantation, and life expectancy longer than six months.
Exclusion criteria
1 Use of vitamin K antagonists
2 Calcium under 2,1 mmol/l or above 2,6 mmol/l, after correction for albumin level
3 Pregnancy
4 Baseline phosphate under 1,4 mmol/l
5 Allergy or intolerance for study medication
6 PTH <15 or >65 pmol/l
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4902 |
| NTR-old | NTR5004 |
| CCMO | NL36810.094.13 |
| OMON | NL-OMON44005 |
Summary results
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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>
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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>
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18 Sevelamer Summary Product information.<br>
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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.