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…
ID
Bron
Verkorte titel
Aandoening
Vascular calcification, phosphate binders, chronic kidney disease, vitamin K, MGP
Ondersteuning
Shire only study medication support, no financial support
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Absolute difference between serum level of dp-ucMGP and PIVKA II at week 8 between phosphate binder groups (between group analysis).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
treatment with calciumcarbonate or lanthanum carbonate with supplemantation of vitamin K
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Haemodialysis patients aged 18 years or above without the prospect of renal function recovery, planned renal transplantation, and life expectancy longer than six months.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4902 |
| NTR-old | NTR5004 |
| CCMO | NL36810.094.13 |
| OMON | NL-OMON44005 |
Samenvatting resultaten
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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>
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>
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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.