Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
16
Countries
1
Sites
1
Rejection transplanted kidney
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 15 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512553-25-00
- EudraCT number
- 2022-004168-11
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Rejection transplanted kidney
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- H.S. Spijker
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Clinical Research Unit Internal Medicine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Leids Universitair Medisch Centrum (LUMC)
Nephrology, Albinusdreef 2, 2333 ZA, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-10-15 | 2024-10-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Netherlands | Acceptable with conditions 2024-09-30
|
2024-09-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-25 | Netherlands | Acceptable with conditions 2024-09-30
|
2025-08-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-08 | Netherlands | Acceptable with conditions 2024-09-30
|
2025-12-08 |