Calcimimetics Adherence and Preference Study in the Management of Secondary Hyperparathyroidism in Europe

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Evaluation of patient-reported outcomes
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  A multi-country prospective observational cross-sectional survey of patient, nephrologist and dialysis nurses and (primary data collection) and use of secondary data collected from the European Dialysis Outcomes and Practice Patterns Study

Study drug and medical condition

• Medical condition to be studied:
  Hyperparathyroidism secondary

Population studied

• Short description of the study population:
  The study population will consist of adult chronic HD patients who are prescribed oral cinacalcet or IV etelcalcetide at the time they are approached for study participation. Data will be collected via a questionnaire on calcimimetic self-reported adherence (primary data). Nephrologists and dialysis nurses at each participating dialysis facility with experience prescribing and/or administering calcimimetics will complete a questionnaire on calcimimetic preference for management of SHPT. Questionnaires will be piloted prior to the conduct of the study.; In addition, patient and nephrologist questionnaires will be linked with data collected from DOPPS 7 (secondary data) to understand whether there are clusters of patient (eg, clinical parameters), nephrologist, and facility-level factors that might be associated with patient adherence and nephrologist/dialysis nurse preferences.; ; Patients; Adults aged ≥18, receiving chronic HD and are prescribed oral cinacalcet or intravenous etelcalcetide at the time they are approached for study participation; and; provide written informed consent according to local requirements. Patients who have been diagnosed with dementia or hospitalized in the last 4 weeks prior to being approached for the study will be excluded. ; ; Nephrologist and dialysis nurse; The nephrologists and dialysis nurses at participating dialysis facilities with experience prescribing and/or administering calcimimetics will be included.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  400

Study design details

• Main study objective:
  The Calcimimetic Adherence and Preference (CAP) study will provide relevant patient-reported outcome (PRO) data from a real-world clinical setting in terms of patient adherence and preference from the nephrologist and dialysis nurse perspective.
• Outcomes:
  - To describe the level of self-reported adherence among haemodialysis patients prescribed oral cinacalcet versus IV etelcalcetide for managing SHPT- To describe the level of preference for IV etelcalcetide compared to oral cinacalcet for managing secondary hyperparathyroidism among nephrologists and nurses. To describe treatment persistence of calcimimetics, patient’s belief about treatment intrusiveness with calcimimetic adherence, patient’s experience of symptoms with calcimimetic adherence, associations between nephrologist/nurse calcimimetic preference and site SHPT management practices, patient-level factors and site level SHPT management practices and associations with calcimimetic adherence.
• Data analysis plan:
  Scoring of adherence and preference levels will be carried out according to validated MARS, BMQ-specific, TIS, KDQOL, and HPPS tools. Descriptive statistics (number frequency, mean, median, SD, IQR and range) will be carried out. For models of association, covariates may be entered in hierarchical groups to assess the incremental and overall effects on the outcomes. Quantile categorization and spline regression methods may be used to identify appropriate functional forms of continuous variables. Associations will be reported with either 95% CI or standard error values with p-values.