Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
36
Countries
1
Sites
2
Chronic Kidney Disease
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-11-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Kidney Disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 36 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-26 | Germany | Acceptable 2025-11-12
|
2025-11-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-02 | Germany | Acceptable 2025-11-12
|
2025-12-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-04 | Germany | Acceptable 2025-11-12
|
2026-02-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-27 | Germany | Acceptable 2026-03-05
|
2026-03-11 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-12 | Germany | Acceptable 2026-03-05
|
2026-03-12 |