Mortality in kidney disease patients treated with phosphate binders: a randomized study

Clin J Am Soc Nephrol. 2012 Mar;7(3):487-93. doi: 10.2215/CJN.03820411. Epub 2012 Jan 12.


Background and objectives: Dietary phosphorous overload and excessive calcium intake from calcium-containing phosphate binders promote coronary artery calcification (CAC) that may contribute to high mortality of dialysis patients. CAC has been found in patients in early stages of nondialysis-dependent CKD. In this population, no study has evaluated the potential role of phosphorus binders on mortality. This study aimed to evaluate all-cause mortality as the primary end point in nondialysis-dependent CKD patients randomized to different phosphate binders; secondary end points were dialysis inception and the composite end point of all-cause mortality and dialysis inception.

Design, setting, participants, & measurements: This is a randomized, multicenter, nonblinded pilot study. Consecutive outpatients (n=212; stage 3-4 CKD) were randomized to either sevelamer (n=107) or calcium carbonate (n=105). Phosphorus concentration was maintained between 2.7 and 4.6 mg/dl for patients with stage 3-4 CKD and between 3.5 and 5.5 mg/dl for patients with stage 5 CKD. The CAC score was assessed by computed tomography at study entry and after 6, 12, 18, and 24 months. All-cause mortality, dialysis inception, and the composite end point were recorded for up to 36 months.

Results: In patients randomized to sevelamer, all-cause mortality and the composite end point were lower; a nonsignificant trend was noted for dialysis inception.

Conclusions: Sevelamer provided benefits in all-cause mortality and in the composite end point of death or dialysis inception but not advantages in dialysis inception. Larger studies are needed to confirm these results.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Biomarkers / blood
  • Calcium Carbonate / adverse effects
  • Calcium Carbonate / therapeutic use*
  • Cause of Death
  • Chelating Agents / adverse effects
  • Chelating Agents / therapeutic use*
  • Coronary Angiography
  • Coronary Artery Disease / blood
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality*
  • Female
  • Humans
  • Italy
  • Kidney Diseases / blood
  • Kidney Diseases / complications
  • Kidney Diseases / drug therapy*
  • Kidney Diseases / mortality
  • Male
  • Middle Aged
  • Phosphates / blood*
  • Phosphorus / blood
  • Pilot Projects
  • Polyamines / adverse effects
  • Polyamines / therapeutic use*
  • Renal Dialysis / mortality
  • Sevelamer
  • Survival Analysis
  • Time Factors
  • Treatment Outcome
  • Vascular Calcification / blood
  • Vascular Calcification / diagnostic imaging
  • Vascular Calcification / mortality*


  • Biomarkers
  • Chelating Agents
  • Phosphates
  • Polyamines
  • Phosphorus
  • Sevelamer
  • Calcium Carbonate