An Observational Registry Study To Evaluate The Use And Safety Of Cinacalcet Among Paediatric Patients With Secondary Hyperparathyroidism (20180204)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective and prospective chart review study

Study drug and medical condition

• Name of medicine:
  Mimpara
• Study drug International non-proprietary name (INN) or common name:
  CINACALCET
• Anatomical Therapeutic Chemical (ATC) code:
  (H05BX01) cinacalcet
• Medical condition to be studied:
  Hypocalcaemia

  Hyperparathyroidism secondary

Population studied

• Short description of the study population:
  The registry will enrol eligible paediatric patients on maintenance dialysis who are prescribed cinacalcet treatment.
• Age groups:
  Paediatric Population (< 18 years)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  45

Study design details

• Main study objective:
  To describe patient characteristics, how cinacalcet is used, laboratory values over time, the incidence of hypocalcaemia, risk factors associated with time to hypocalcaemia event and management of hypocalcaemia in paediatric patients with secondary hyperparathyroidism (sHPT).
• Outcomes:
  In a European cohort of paediatric patients with sHPT on maintenance dialysis and using cinacalcet: To describe the patient characteristics, how cinacalcet is used, the laboratory values (PTH, cCa, phosphate and albumin) over time and the incidence, management and risk factors associated with hypocalcaemia.
• Data analysis plan:
  There are no formal hypotheses for the study. Descriptive data analyses will be performed. Characteristics of patients who develop and do not develop hypocalcaemia will be described. Treatment characteristics (cinacalcet and other sHPT medications) will be summarised prior to cinacalcet initiation and after a hypocalcaemia event. PTH, cCa, phosphate and albumin laboratory parameters over time will be summarised. To describe time-to-event of first hypocalcaemia event, cinacalcet discontinuation and cinacalcet re-initiation, Kaplan-Meier (KM) curves will be calculated.