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Randomized Controlled Trial
. 2013;38(2):158-67.
doi: 10.1159/000353569. Epub 2013 Aug 7.

Effects of phosphate binder therapy on vascular stiffness in early-stage chronic kidney disease

Michael E Seifert  1 , Lisa de las Fuentes, Marcos Rothstein, Dennis J Dietzen, Andrew J Bierhals, Steven C Cheng, Will Ross, David Windus, Víctor G Dávila-Román, Keith A Hruska
Affiliations
Randomized Controlled Trial

Effects of phosphate binder therapy on vascular stiffness in early-stage chronic kidney disease

Michael E Seifert et al. Am J Nephrol. 2013.

Abstract

Background/aims: Cardiovascular disease (CVD) is increased in chronic kidney disease (CKD), and contributed to by the CKD-mineral bone disorder (CKD-MBD). CKD-MBD begins in early CKD and its vascular manifestations begin with vascular stiffness proceeding to increased carotid artery intima-media thickness (cIMT) and vascular calcification (VC). Phosphorus is associated with this progression and is considered a CVD risk factor in CKD. We hypothesized that modifying phosphorus balance with lanthanum carbonate (LaCO3) in early CKD would not produce hypophosphatemia and may affect vascular manifestations of CKD-MBD.

Methods: We randomized 38 subjects with normophosphatemic stage 3 CKD to a fixed dose of LaCO3 or matching placebo without adjusting dietary phosphorus in a 12-month randomized, double-blind, pilot and feasibility study. The primary outcome was the change in serum phosphorus. Secondary outcomes were changes in measures of phosphate homeostasis and vascular stiffness assessed by carotid-femoral pulse wave velocity (PWV), cIMT and VC over 12 months.

Results: There were no statistically significant differences between LaCO3 and placebo with respect to the change in serum phosphorus, urinary phosphorus, tubular reabsorption of phosphorus, PWV, cIMT, or VC. Biomarkers of the early CKD-MBD such as plasma fibroblast growth factor-23, Dickkopf-related protein 1 (DKK1), and sclerostin were increased 2- to 3-fold at baseline, but were not affected by LaCO3.

Conclusion: Twelve months of LaCO3 had no effect on serum phosphorus and did not alter phosphate homeostasis, PWV, cIMT, VC, or biomarkers of CKD-MBD.

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Conflict of interest statement

Conflict of Interest:

K.A.H. has been a consultant for or the recipient of research funding from Shire, Genzyme and Fresenius.

Figures

Figure 1
Figure 1. Enrollment Flowchart and Randomization Strategy
Figure 2
Figure 2. Effect of LaCO3 on Pulse Wave Velocity
Boxplot representation of carotid-femoral pulse wave velocity data at baseline and the 12-month visit in each group. The line in the shaded area is the median value, the top of the shaded area is the 75th percentile, the bottom of the shaded area is the 25th percentile and the whiskers represent the range of the values.
Figure 3
Figure 3. Urinary phosphate and FGF23 levels in the LaCO3 and placebo groups at baseline and at 12 months
Boxplot representation of (A), Urinary Phosphate and (B), FGF23 levels at baseline and 12 months. Median values are the horizontal lines within the shaded areas. The shaded areas represent the 75th (top) to 25th (bottom) percentiles, and the vertical lines with whiskers represent the full range.
Figure 3
Figure 3. Urinary phosphate and FGF23 levels in the LaCO3 and placebo groups at baseline and at 12 months
Boxplot representation of (A), Urinary Phosphate and (B), FGF23 levels at baseline and 12 months. Median values are the horizontal lines within the shaded areas. The shaded areas represent the 75th (top) to 25th (bottom) percentiles, and the vertical lines with whiskers represent the full range.
See this image and copyright information in PMC

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