Characterizing the Management of Hypocalcemia Among Patients on Hemodialysis Receiving Cinacalcet Treated Within a Large US Dialysis Provider (20140132)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11232
• EU PAS number:
  EUPAS6210
• Study ID:
  11232
• Official title and acronym:
  Characterizing the Management of Hypocalcemia Among Patients on Hemodialysis Receiving Cinacalcet Treated Within a Large US Dialysis Provider (20140132)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To compare characteristics (demographic, clinical, and laboratory values) of patients on hemodialysis who develop hypocalcemia while on cinacalcet with the characteristics of patients who do no develop hypocalcemia while on cinacalcet, and to characterize the management of hypocalcemia among patients on hemodialysis receiving cinacalcet using data from the DaVita® Rx database and the DaVita Clinical Data Warehouse patient electronic medical records.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

DaVita Clinical Research Minneapolis, Minnesota, USA

Study timelines

Date when funding contract was signed

Actual: 08/11/2013

Study start date

Actual: 14/03/2014

Data analysis start date

Planned: 02/05/2014

Actual: 15/10/2014

Date of final study report

Planned: 01/05/2015

Actual: 02/10/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Cinacalcet_20140132_Protocol_21Apr14

Regulatory

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