Clinical trial • Phase III • Haematology
epoetin alfa for Renal anaemia | Anaemia of chronic kidney disease
Phase III trial of epoetin alfa for Renal anaemia | Anaemia of chronic kidney disease.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Renal anaemia | Anaemia of chronic kidney disease
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 15-01-2026
- First CTIS Authorization Date
- 13-03-2026
Trial design
Erypo compared with epoetin alfa (Blau EPO); doses and schedule not specified in the record.-controlled Phase III trial across 1 site in Germany.
- Comparator
- Erypo compared with epoetin alfa (Blau EPO); doses and schedule not specified in the record.
- Target Sample Size
- 64
Eligibility
Recruits 64 Vulnerable population selected (isVulnerablePopulationSelected = true). Population: Healthy volunteers. No details on consent or assent processes are provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Population: Healthy volunteers. No details on consent or assent processes are provided in the record.
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 8
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 64
Germany
- Earliest CTIS Part Ii Submission Date
- 04-03-2026
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 9
- Number Of Sites
- 1
- Number Of Participants
- 64
Sites
- Site Name
- Nuvisan GmbH
- Department Name
- Clinical Services
- Contact Person Name
- Michael Lissy
- Contact Person Email
- michael.lissy@nuvisan.com
Sponsor
Primary sponsor
- Full Name
- Blau Farmaceutica S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Brazil
Investigational products
- Investigational Product Name
- Blau EPO (epoetin alfa)
- Active Substance
- epoetin alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- intravenous injection
- Route
- intravenous
- Frequency
- single intravenous injection
- Investigational Product Name
- Erypo
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- intravenous injection
- Route
- intravenous
- Frequency
- single intravenous injection
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