Key result
New trial protocol compares sevelamer and calcium binders for vascular calcification mortality in incident hemodialysis patients.
RCT (n=360)
randomized
Yes
Answers are grounded in this paper and cite their sources.
No results yet from this protocol; leaves open sevelamer versus calcium-binder outcomes in incident hemodialysis pending trial completion.
This study proposes [corrected] to evaluate the impact of different phosphate binders on the slowing of [corrected]cardiovascular calcification [corrected] and QT dispersion in incident haemodialysis patients with a follow-up of [corrected] 36 months. This is to be a [corrected] randomized, multicenter, perspective, [corrected] interventional study. Inclusion criteria are age over 18 years and being an [corrected] incident patient [corrected] on hemodialysis. Exclusion criteria are congenital prolongation of QT segment syndrome, QT-c >440 ms, bradycardia <50 beats per minute, symptomatic [corrected] arrhythmia or any other significant heart problems; electrolyte imbalances [corrected] (especially hypokalemia, hypomagnesemia or [corrected] hypocalcemia); abnormal liver function tests and [corrected] hypothyroidism. An informed consent will be taken at study entry. The patients will be randomized to 2 cohorts: [corrected] 180 patients in the sevelamer [corrected] group and 180 patients in calcium-binder phosphate group. Related vascular calcification mortality is the principal end point [corrected] and will be evaluated at 36 months.
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Iorio et al. (2009) conducted an RCT in incident hemodialysis (n=360). Sevelamer vs. Calcium-binder phosphate was evaluated on Related vascular calcification mortality. This abstract describes a study protocol for a randomized trial comparing sevelamer and calcium-binder phosphate in 360 incident hemodialysis patients, with no results reported.
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