A Prospective Cohort Study to Describe Use and Safety of Cinacalcet in Pediatric Patients Receiving Dialysis in the NAPRTCS Registry (20120116)

Study type

• Study topic:
  Disease /health condition

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

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Sensipar
• Medical condition to be studied:
  Central hypothyroidism

Population studied

• Short description of the study population:
  All patients < 21 years of age receiving maintenance dialysis for chronic kidney disease (CKD) at a North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) affiliated center, and who were enrolled in the registry.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Describe the demographics, laboratory values, and secondary hyperparathyroidism (SHPT) medication use (specifically cinacalcet), and the occurrence of hypocalcemia, seizures, and infections (requiring hospitalization), in cinacalcet treated and untreated patients enrolled in the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) receiving dialysis for chronic kidney disease.
• Outcomes:
  Demographic characteristics, laboratory values (PTH, calcium, phosphorus), SHPT medication use, occurrence of clinical events (hypocalcemia, seizures, infections requiring hospitalization).
• Data analysis plan:
  The analyses will describe the study population and outcomes as follows: 1) total number of patients and total number of patient-years observation based on the annual data reporting periods, and for the cumulative 3-year study period, 2)estimation of rates of cinacalcet use based on the annual data reporting periods, andfor the cumulative 3-year study period, 3) estimation of rates of AESI based on the annual data reporting periods, and for the cumulative 3-year study period, 4)proportion of patients who received at least 1 dose of cinacalcet within 7 days preceding an episode of hypocalcemia (from amongst all patients who developed hypocalcemia). Descriptive analyses using summary statistics will also be conducted to tabulate baseline demographic and clinical characteristics by cinacalcet-exposed and cinacalcet unexposed. The cinacalcet utilization pattern will also be assessed (eg, dosing, duration of treatment).

Documents

Study results

20120116_ORSR_Abstract