Clinical trial • Phase III • Haematology
epoetin alfa for Anemia of chronic kidney disease | Renal anemia
Phase III trial of epoetin alfa for Anemia of chronic kidney disease | Renal anemia.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Anemia of chronic kidney disease | Renal anemia
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 05-02-2026
- First CTIS Authorization Date
- 02-04-2026
Trial design
Epoetin alfa (Blau EPO) versus Erypo; administered as multiple intravenous injections; doses/schedule not specified.-controlled Phase III trial across 1 site in Germany.
- Comparator
- Epoetin alfa (Blau EPO) versus Erypo; administered as multiple intravenous injections; doses/schedule not specified.
- Target Sample Size
- 124
Eligibility
Recruits 124 No vulnerable populations selected; participants are healthy adult males; no assent/consent handling details provided..
- Vulnerable Population
- No vulnerable populations selected; participants are healthy adult males; no assent/consent handling details provided.
Recruitment
- Planned Sample Size
- 124
- Recruitment Window Months
- 8
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 124
Germany
- Earliest CTIS Part Ii Submission Date
- 19-03-2026
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 124
Sites
- Site Name
- Nuvisan GmbH
- Department Name
- Clinical Services
- Contact Person Name
- Michael Lissy (Physician)
- 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
- epoetin alfa (Blau EPO)
- Active Substance
- epoetin alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- intravenous
- Route
- intravenous
- Frequency
- multiple intravenous injections
- Investigational Product Name
- Erypo
- Active Substance
- epoetin alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- intravenous
- Route
- intravenous
- Frequency
- multiple intravenous injections
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