Study Complete
Sponsor ID
20140336
A Single-dose Study in Paediatric Patients Aged 2 to less than 18 Years with Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
Study Details
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
Protocol Summary
Primary Outcome Measures
Common Treatment emergent AEs
Timeframe: 30 days
Changes in Key Laboratory Tests
Timeframe: 30 days
Changes in ECG
Timeframe: 30 days
Changes in Vital Signs
Timeframe: 30 days
Secondary Outcome Measures
AUC (PK parameter)
Timeframe: 30 days
Concentration of parathyroid hormone (PTH) (PD parameter)
Timeframe: 30 days
Anti-drug antibodies
Timeframe: 30 days
Treatment emergent AEs
Timeframe: 30 days
Cmax (PK parameter)
Timeframe: 30 days
Tmax (PK parameter)
Timeframe: 30 days
Serum calcium [total calcium, ionized calcium and albumin corrected calcium] over time (PD parameter)
Timeframe: 30 days
Study Documents
Plain Language Summary of Results
Available Language(s): English, Dutch (Belgium), German, Lithuanian, Polish, Romanian, French (Belgium)
Locations
Location
Research Site
Bruxelles, Belgium, 1020
Status
Completed
Location
Research Site
Gent, Belgium, 9000
Status
Completed
Location
Research Site
Hannover, Germany, 30625
Status
Recruiting
Location
Research Site
Heidelberg, Germany, 69120
Status
Recruiting
Location
Research Site
Leuven, Belgium, 3000
Status
Completed
Location
Research Site
Marburg, Germany, 35043
Status
Completed
Showing {first} - {last} of {total} Results