Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
72
Countries
1
Sites
2
Chronic kidney disease
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 7 Aug 2024 → 21 Nov 2025
- Decision date (initial)
- 2024-07-30
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10064848 | Chronic kidney disease | 100000004857 |
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 | Ended | 72 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2024-08-07 | 2025-11-21 | 2024-08-16 | 2025-10-08 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-26 | Germany | Acceptable 2024-07-29
|
2024-07-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-02 | Germany | Acceptable 2024-07-29
|
2024-08-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-09 | Germany | Acceptable 2024-07-29
|
2024-10-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-27 | Germany | Acceptable 2025-03-21
|
2025-04-01 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-17 | Germany | Acceptable 2025-03-21
|
2025-10-17 |