A computerized treatment algorithm trial to optimize mineral metabolism in ESRD

Clin J Am Soc Nephrol. 2012 Apr;7(4):632-9. doi: 10.2215/CJN.08170811. Epub 2012 Feb 2.

Abstract

Background and objectives: Achievement of mineral targets in patients receiving dialysis remains challenging. This study sought to evaluate outcomes for phosphorus, calcium, and parathyroid hormone when a dialysis population was switched from a predominantly active vitamin D analogue treatment regimen to a computerized algorithm incorporating both cinacalcet and active vitamin D as potential first-line therapies.

Design, setting, participants, & measurements: This longitudinal prospective trial enrolled 92 patients undergoing maintenance hemodialysis. Baseline measures (the average of the 3 months before computerized algorithm implementation) were compared with the proportion of patients achieving the prespecified targets at 6 and 12 months.

Results: After 6 months there was a statistically significant improvement in the percentage of patients achieving the primary and secondary phosphorus targets (primary: phosphorus ≤ 5.5 mg/dl, increase from 41% to 75%, P<0.001; secondary: phosphorus 3.0-4.6 mg/dl, increase from 16% to 38%; P=0.005). These improvements were sustained at 12 months. There was a statistically significant improvement in the percentage of patients achieving all three prespecified secondary endpoints (an increase from 12.8% to 25.6% at 12 months; P=0.04); however, this was mainly driven by improved phosphorus control. The proportion of patients achieving the primary or secondary parathyroid hormone targets did not improve.

Conclusions: A greater proportion of dialysis patients achieved improved phosphorus but not parathyroid hormone control by switching from a predominantly active vitamin D analogue-based treatment regimen for mineral and bone disorder to a computer-driven algorithm that incorporated cinacalcet and low-dose active vitamin D analogues as first-line therapy.

Trial registration: ClinicalTrials.gov NCT01100723.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Algorithms*
  • Biomarkers / blood
  • Calcimimetic Agents / administration & dosage*
  • Calcium / blood
  • Cinacalcet
  • Drug Substitution
  • Drug Therapy, Computer-Assisted*
  • Female
  • Humans
  • Kidney Failure, Chronic / blood
  • Kidney Failure, Chronic / complications
  • Kidney Failure, Chronic / therapy*
  • Longitudinal Studies
  • Male
  • Metabolic Diseases / blood
  • Metabolic Diseases / drug therapy*
  • Metabolic Diseases / etiology
  • Middle Aged
  • Naphthalenes / administration & dosage*
  • Parathyroid Hormone / blood
  • Phosphorus / blood
  • Prospective Studies
  • Renal Dialysis* / adverse effects
  • Time Factors
  • Treatment Outcome
  • Vitamin D / administration & dosage*
  • Vitamins / administration & dosage*

Substances

  • Biomarkers
  • Calcimimetic Agents
  • Naphthalenes
  • PTH protein, human
  • Parathyroid Hormone
  • Vitamins
  • Vitamin D
  • Phosphorus
  • Calcium
  • Cinacalcet

Associated data

  • ClinicalTrials.gov/NCT01100723