Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
47
Countries
3
Sites
10
Chronic Kidney disease
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 5 Mar 2025 → 28 Oct 2025
- Decision date (initial)
- 2025-02-17
- 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 |
|---|---|---|---|---|
| 21.1 | LLT | 10051614 | Arteriosclerotic cardiovascular disease | 10047065 |
| 23.1 | PT | 10064848 | Chronic kidney disease | 100000004857 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information center
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 10 | 4 |
| Hungary | Ended | 7 | 3 |
| Romania | Ended | 19 | 3 |
| Rest of world
United States
|
— | 11 | — |
Investigational sites
Multi-profile Hospital for Active Treatment Heart and Brain EAD
0901:Cardiology Department, Pierre Curie Street 2, 5804, Pleven
University Hospital St. Anna
0903:Department of Cardiology at First Clinic of Internal Diseases, Ulitsa Dimitir Mollov 1, 1750, Sofia
Acibadem City Clinic University Hospital EOOD
0904:Clinic of Cardiology, Ulitsa Okolovristen Pit 127, 1407, Sofia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
0902:Cardiology Clinic, Oborishte Distr., Ul.Byalo More 8, Sofia
Clinexpert Kft.
3302:Phase I. Clinical Trial Site, Dozsa Gyorgy Utca 15, 3200, Gyongyos
Semmelweis University
3303:Belgyógyászati és Onkológiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
CRU Hungary Kft.
3301: Phase I. Clinical Pharmacology Trial Site, Semmelweis Ter 1, 2143, Kistarcsa
Nova-Clin Medical Research Center S.R.L.
6103:Clinic, Strada Rigoletto 14, 300732, Timisoara
Spitalul Clinic Judetean De Urgenta Cluj
6102:Internal Medicine, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
6101:, Intrarea Tudor Stefan 38-40, 011658, Bucharest
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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-03-05 | 2025-10-10 | 2025-03-05 | 2025-08-13 | |
| Hungary | 2025-03-24 | 2025-09-23 | 2025-03-24 | 2025-08-18 | |
| Romania | 2025-03-12 | 2025-10-27 | 2025-03-12 | 2025-08-06 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Hungary | Acceptable 2025-02-10
|
2025-02-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-11 | Acceptable 2025-02-10
|
2025-07-11 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-14 | Acceptable 2025-02-10
|
2025-07-14 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-17 | Hungary | Acceptable 2025-02-10
|
2025-07-17 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-09-15 | Hungary | Acceptable 2025-02-10
|
2025-09-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-29 | Hungary | Acceptable 2025-12-11
|
2025-12-15 |