Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
124
Countries
2
Sites
3
Chronic Kidney Disease
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Decision date (initial)
- 2026-02-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520978-18-00
- WHO UTN
- U1111-1327-9750
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
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 12 | 1 |
| Romania | Authorised, recruitment pending | 32 | 2 |
| Rest of world
United States
|
— | 80 | — |
Investigational sites
Spitalul Clinic Judetean De Urgenta Cluj
3002: Internal Medicine, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
3001: Nephrology, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-14 | Romania | Acceptable 2026-02-09
|
2026-02-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-20 | Romania | Acceptable 2026-02-09
|
2026-02-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-25 | Acceptable 2026-02-09
|
2026-03-25 |