Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
64
Countries
1
Sites
1
It is used to treat symptomatic anaemia in chronic renal failure
Key facts
- Sponsor
- Blau Farmaceutica S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2026-03-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
It is used to treat symptomatic anaemia in chronic renal failure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10058132 | Renal anemia | 10005329 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Blau Farmaceutica S.A.
2
Total trials
Commercial
- Sponsor organisation
- Blau Farmaceutica S.A.
- Address
- Rodovia Raposo Tavares Km 30 5, Jardim Dinorah Jardim Dinorah
- City
- Cotia
- Postcode
- 06703-030
- Country
- Brazil
Scientific contact point
- Organisation
- Blau Farmaceutica S.A.
- Contact name
- Clinical Research team
Public contact point
- Organisation
- Blau Farmaceutica S.A.
- Contact name
- Clinical Research team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 64 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-15 | Germany | Acceptable with conditions 2026-03-13
|
2026-03-13 |