Calcimimetics Adherence and Preference Study in the Management of Secondary Hyperparathyroidism in Europe

Study identification

• EU PAS number:
  EUPAS27845
• Study ID:
  46905
• Official title and acronym:
  Calcimimetics Adherence and Preference Study in the Management of Secondary Hyperparathyroidism in Europe
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Spain

  Sweden

  United Kingdom
• Study description:
  Data from clinical trials and real-life clinical practice have demonstrated the effectiveness of cinacalcet in reducing PTH. In a controlled clinical trial comparing etelcalcetide with cinacalcet, etelcalcetide was found to be at least as effective as cinacalcet in reducing PTH by more than 30% after a minimum of 20 weeks’ treatment, and no difference in adherence was observed However, the effectiveness of etelcalcetide in clinical practice might be substantially different in real-life clinical practice (e.g. adherence). There are also no data on physician and nurse’s calcimimetic preference. Given the lack of real-world data describing medication adherence, preference and consequently achievement of PTH control of etelcalcetide following initial marketing authorization in Europe, the Calcimimetic Adherence and Preference (CAP) study will provide relevant patient-reported outcome (PRO) data from a real-world clinical setting from the patient, nephrologist and dialysis nurse perspective.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 120 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:15/11/2017

Actual:15/11/2017

Study start date

Planned:11/10/2019

Actual:04/10/2019

Data analysis start date

Planned:25/10/2021

Actual:09/09/2021

Date of final study report

Planned:15/04/2022

Actual:25/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable