Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
36
Countries
2
Sites
6
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]
- Decision date (initial)
- 2026-02-09
- 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 |
|---|---|---|---|---|
| 20.0 | PT | 10011078 | Coronary artery disease | 100000004849 |
| 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
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 10 | 2 |
| Germany | Authorised, recruitment pending | 26 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Medical Center Comac Medical Ltd.
NA, Ulitsa Urvich 13, Krasno Selo District, Sofia
Medical Center Comac Medical Ltd.
NA, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofia
SocraTec R&D Concepts in Drug Research and Development GmbH
Clinical Pharmacology Unit, Mainzerhofplatz 14, Erfurt-Altstadt, Erfurt
Charite Universitaetsmedizin Berlin KöR
Kardiologie, Angiologie und Intensivmedizin CVK, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Heidelberg AöR
Klinische Pharmakologie und Pharmakoepidemologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Bonn AöR
Phase I Einheit und Arzneimitteltherapiesicherheit, Venusberg-Campus 1, Venusberg, Bonn
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-08 | Germany | Acceptable 2026-01-19
|
2026-01-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-12 | Germany | Acceptable 2026-01-19
|
2026-02-12 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-23 | Germany | Acceptable 2026-01-19
|
2026-02-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-27 | Acceptable | 2026-04-03 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-08 | Germany | Acceptable | 2026-04-08 |