Study identification

EU PAS number

EUPAS14525

Study ID

49342

Official title and acronym

Multicenter non-interventional post-authorization safety study (NI-PASS) to monitor the incidence of relevant and expected rare adverse events including lack of efficacy among CKD patients receiving s.c. Binocrit® or Epoetin alfa HEXAL®

DARWIN EU® study

No

Study countries

Bulgaria
Croatia
Germany
Greece
Italy
Poland
Romania
Slovakia
Slovenia
Spain

Study description

This is a non-interventional study to address the post-authorization requirement to evaluate the safety profile of Binocrit® and Epoetin alfa HEXAL® administered sub-cutaneously (s.c.) in patients with chronic kidney disease (CKD)-induced anemia under real life conditions. The purpose of this non-interventional Post-Authorization Safety Study is to increase dataset on the safe use of the product by extending the safety database of patients with CKD-induced anemia who receive s.c. Binocrit® or Epoetin alfa HEXAL® treatment and by monitoring closely the adverse event profile under real-life post-approval conditions.

Study status

Ongoing
Research institutions and networks

Institutions

Sandoz
First published:
01/02/2024
Institution
129 centres involved in the study

Contact details

Sandoz Clinical Disclosure Office

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Hexal AG
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)