Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
30
Countries
2
Sites
2
late antibody mediated renal transplant rejection
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 7 Sep 2021 → ongoing
- Decision date (initial)
- 2024-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511764-86-00
- EudraCT number
- 2021-000545-40
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
late antibody mediated renal transplant rejection
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Nephrology and Dialysis, Department of Medicine III
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Nephrology and Dialysis, Department of Medicine III
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 20 | 1 |
| Germany | Ongoing, recruiting | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Medical University Of Vienna
Division of Nephrology and Dialysis, Department of Medicine III, Waehringer Guertel 18-20, Alsergrund, Vienna
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 |
|---|---|---|---|---|---|
| Austria | 2021-09-07 | 2021-10-28 | |||
| Germany | 2024-12-11 | 2024-12-11 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Austria | Acceptable 2024-12-06
|
2024-12-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-17 | Acceptable | 2025-02-28 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-17 | Austria | Acceptable | 2025-04-28 |