Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
1
Sites
1
Chronic Kidney Disease
Key facts
- Sponsor
- Bayer AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- completed 22 May 2026
- Decision date (initial)
- 2026-03-09
- 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
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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-16 | Germany | Acceptable 2026-02-17
|
2026-03-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-10 | Germany | Acceptable 2026-02-17
|
2026-03-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-24 | Germany | Acceptable 2026-02-17
|
2026-03-24 |