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
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