A Multi-country Prospective Observational Study to Describe Calcimimetic Use in Haemodialysis Patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48608
• EU PAS number:
  EUPAS18923
• Study ID:
  48608
• Official title and acronym:
  A Multi-country Prospective Observational Study to Describe Calcimimetic Use in Haemodialysis Patients
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Czechia

  Denmark

  France

  Germany

  Greece

  Hungary

  Israel

  Italy

  Netherlands

  Portugal

  Russian Federation

  Spain

  United Kingdom
• Study description:
  In Europe, two calcimimetics, cinacalcet (Mimpara®) and etelcalcetide (Parsibiv®) are approved for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD). Mimpara is approved for patients treated with maintenance dialysis, whilst etelcalcetide has been approved for patients specifically receiving haemodialysis (HD) therapy. Oral cinacalcet was the first calcimimetic to be approved by the European Medicines Agency (EMA) that was granted marketing authorization in 2004. An intravenous (i.v.) calcimimetic, etelcalcetide, received marketing authorisation from the EMA in November 2016. Data from clinical trials and real-life clinical practice have demonstrated the effectiveness of cinacalcet in reducing PTH levels. 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, there is a lack of real-world data describing achievement of PTH control and medication persistence of etelcalcetide. This observational study will describe parameters of drug utilisation of both etelcalcetide and cinacalcet in a contemporary real world clinical setting.
• 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

Actual: 07/11/2016

Study start date

Planned: 11/12/2017

Actual: 07/06/2018

Data analysis start date

Planned: 22/12/2021

Actual: 10/03/2022

Date of final study report

Planned: 22/06/2022

Actual: 16/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20150297 Abstract

Updated protocol

01.02.06 Public Redacted Protocol Ver 1.0 2020-03-06 English

Regulatory

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