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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17576
• EU PAS number:
  EUPAS5647
• Study ID:
  17576
• Official title and acronym:
  A Prospective Cohort Study to Describe Use and Safety of Cinacalcet in Pediatric Patients Receiving Dialysis in the NAPRTCS Registry (20120116)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Costa Rica

  Mexico

  United States
• Study description:
  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 (CKD).
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

North American Pediatric Renal Trials and Collaborative Studies Boston, MA, USA

Study timelines

Date when funding contract was signed

Actual: 22/06/2012

Study start date

Actual: 01/08/2012

Data analysis start date

Actual: 01/08/2013

Date of interim report, if expected

Actual: 01/10/2013

Date of final study report

Planned: 22/07/2016

Actual: 31/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Cinacalcet_20120116_Protocol_11Feb14

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable