Effect of Cinacalcet Discontinuation on Biochemical Control for Medicare Beneficiaries with Part D Coverage Treated within a Large US Dialysis Provider (20130335)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9776
• EU PAS number:
  EUPAS5641
• Study ID:
  9776
• Official title and acronym:
  Effect of Cinacalcet Discontinuation on Biochemical Control for Medicare Beneficiaries with Part D Coverage Treated within a Large US Dialysis Provider (20130335)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To identify risk factors of discontinuation and reinitiation of cinacalcet, and to describe the trajectory of parathyroid hormone, calcium, and phosphorus laboratory values following the discontinuation of cinacalcet following cinacalcet discontinuation using data from the United States Renal Data System including Medicare Part D prescription claims merged with dialysis provider data from DaVita (one of the largest dialysis providers in the US).
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

University of North Carolina at Chapel Hill

University of North Carolina at Chapel Hill Chapel Hill, NC, USA

Study timelines

Date when funding contract was signed

Actual: 16/09/2013

Study start date

Actual: 01/12/2013

Data analysis start date

Planned: 01/02/2014

Date of final study report

Planned: 01/02/2015

Actual: 20/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Cinacalcet_20130335_Protocol_11Feb14

Regulatory

• Was the study required by a regulatory body?:
  No