Real World Evidence of Safety and Dosing of Mircera in Children with Chronic Kidney Disease

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44502
• EU PAS number:
  EUPAS28490
• Study ID:
  44502
• Official title and acronym:
  Real World Evidence of Safety and Dosing of Mircera in Children with Chronic Kidney Disease
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The study aims to further characterize safety, dosing and related hemoglobin concentrations and to validate the dose simulation models of Mircera in pediatric patients with anemia due to CKD in a real-world setting.
• Study status:
  Finalised

Research institutions and networks

Networks

International Pediatric Dialysis Network (IPDN)

European Union

Study timelines

Date when funding contract was signed

Planned: 22/08/2018

Actual: 22/08/2018

Study start date

Planned: 01/03/2019

Actual: 21/01/2019

Date of interim report, if expected

Planned: 29/11/2019

Actual: 24/10/2019

Date of final study report

Planned: 31/12/2021

Actual: 29/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Hoffmann La Roche

Study protocol

Initial protocol

Prot MH40258 MIRCERA v1, Published Output-1_21 Jan 2019_Redacted.26.2.19_Redacted Encepp

Updated protocol

Prot MH40258 Methoxy Polyethylene Glycol - Epoetin Beta v2, Published Output-1_Redacted

Regulatory

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

Other study registration identification numbers and links

MH40258