Study identification

EU PAS number

EUPAS1000000121

Study ID

1000000121

Official title and acronym

WINE Study: Roxadustat Treatment of Anemia of Chronic Kidney Disease (CKD) in Real-world Clinical Practice - Observational Study Utilizing Routinely Collected Secondary Data from WiNe Registry in Germany

DARWIN EU® study

No

Study countries

Germany

Study description

Erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron have been the standard of care for anemia of chronic kidney disease (CKD) for over 30 years, whereas roxadustat (EVRENZO) was only approved by the European Medicines Agency (EMA) on 18 August 2021 for the treatment of anemia of CKD.

The clinical trial program for roxadustat provides robust evidence of the clinical efficacy and safety of roxadustat in relation to placebo and standard of care.
However, there is a need to generate real-world clinical evidence that better reflects the actual clinical environment in which roxadustat will be used in terms of patient demographics, comorbidities, adherence, and concurrent treatments.
Such data will be a valuable complement to that gathered in clinical trials.

Study status

Finalised
Research institutions and networks

Institutions

Astellas Pharma Europe Ltd.

Contact details

Dr. Frank-Peter Tilmann

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe Ltd.
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable