A Multi-country Prospective Observational Study to Describe Calcimimetic Use in Haemodialysis Patients

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  PARSABIV

  MIMPARA
• Anatomical Therapeutic Chemical (ATC) code:
  (H05BX04) etelcalcetide

  etelcalcetide

  (H05BX01) cinacalcet

  cinacalcet
• Medical condition to be studied:
  Chronic kidney disease

Population studied

• Short description of the study population:
  Patients aged 18 years or older with chronic kidney disease (CKD) receiving hemodalysis therapy (HD) initiated calcimimetic (ie, calcimimetic naïve cinacalcet patients) or etelcalcetide (etelcalcetide patients with or without a history of prior cinacalcet use) treatment after February 2017, outside a clinical trial setting. ; Inclusion criteria: ; • Aged ≥ 18 years and receiving HD for end-stage renal disease (ESRD) at time of calcimimetic initiation; • Patients initiating calcimimetic between date of site-specific etelcalcetide access (eg, known date of first drug order or date of first drug administration at site) to 30 November 2019 or date of site evaluation (ie, evaluation of site for study participation), whichever occurs last, are eligible, specifically:; a) Calcimimetic naïve cinacalcet patients with at least one prescription for cinacalcet; or; b) Etelcalcetide patients with or without a history of prior cinacalcet use and received at least one dose administration of etelcalcetide ; • Provided informed consent or notified of participation, according to local laws and regulations requirements; ; Exclusion criteria: ; • No PTH measurement within 90 days prior to calcimimetic initiation; • Participated in a clinical trial of calcimimetic ≤ 90 days of initiating calcimimetic treatment; • Previously participated in an expanded access program for etelcalcetide
• 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:
  1600

Study design details

• Main study objective:
  To describe the proportion of patients discontinuing treatment at 3-monthly interval up to 18 months following treatment initiation
• Outcomes:
  Proportion of patients discontinuing treatment of calcimimetic at 3-month intervals up to 18 months following calcimimetic initiation, Demographics, clinical characteristics, dialysis parameters, laboratory parameters, calcimimetic use, concomitant sPTH therapy use, events of interest and hypocalcemia incidence
• Data analysis plan:
  Analyses will be descriptive. For continuous variables, descriptive statistics, for example, mean, standard deviation (SD), standard error (ER), median, interquartile range (25th and 75th percentile), minimum, and maximum values will be presented. For categorical variables, the number and percentage of participants in each category will be reported with 95% two-sided confidence intervals (CIs). Variables measured longitudinally (e.g. PTH, Ca and P prior to and after calcimimetic initiation) will also be summarized graphically by plotting the mean (+/- SE) against time.

Documents

Study results

20150297_ORSR_abstract_Redacted ENCEPP