Characterizing the Management of Hypocalcemia Among Patients on Hemodialysis Receiving Cinacalcet Treated Within a Large US Dialysis Provider (20140132)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Hyperparathyroidism secondary

Population studied

• Short description of the study population:
  Patients enrolled in DaVita Rx™ who received hemodialysis at DaVita HealthCare Partners Inc. facilities between 01 January 2011 and 31 December 2013 and filled a prescription of cinacalcet.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  To compare characteristics of patients on hemodialysis who develop hypocalcemia while on cinacalcet with the characteristics of patients who do not develop hypocalcemia while on cinacalcet.To describe patterns of treatment strategies used by physicians.To describe the subsequent recovery of serum calcium.To describe patterns of cinacalcet reinitiation among patients who discontinue.
• Outcomes:
  The development of hypocalcemia.The percent of patients receiving specific treatment responses over the first 30-day interval following the index date of hypocalcemia.The outcome will be the percent of patients who achieve calcium recovery following the index date of hypocalcemia.The percent of patients who re-initiate cinacalcet during the 90 days following cinacalcet discontinuation.
• Data analysis plan:
  Descriptive analyses will be conducted for the distributions of demographic, clinical and laboratory values among patients on hemodialysis who develop hypcalcemia. Baseline characteristics of patients who develop hypocalcemia will be compared to patients who do not develop hypocalcemia. Among patients who develop hypocalcemia, we will describe the percentage receiving specific physician responses and the relevant join distributions of physician responses to the hypocalcemic event. Descriptive analyses for the number and percentage of patients who recover to previous calcium levels dependent on the cut-off used to define hypocalcemia, as well as time-to-event analyses for the overall cumulative incidence of calcium recovery and reinitiation of cinacalcet for patients who discontinue use.