Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
15
Countries
1
Sites
1
patients with cPRA or TGI ≥ 95% on the deceased donor kidney transplant waiting list, who have not received a compatible donor offer for ≥1 year.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Grenoble Alpes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 11 Jan 2022 → 22 Apr 2025
- Decision date (initial)
- 2024-11-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518128-66-00
- EudraCT number
- 2021-002306-27
- ClinicalTrials.gov
- NCT05145296
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
patients with cPRA or TGI ≥ 95% on the deceased donor kidney transplant waiting list, who have not received a compatible donor offer for ≥1 year.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | LLT | 10023418 | Kidney failure | 10038359 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Grenoble Alpes
- Sponsor organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Address
- Boulevard De La Chantourne, Cs 10217, La Tronche Cs 10217 La Tronche
- City
- Grenoble Cedex 9
- Postcode
- 38043
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Malvezzi
Public contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Malvezzi
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Grenoble Alpes
Nephrology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
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 |
|---|---|---|---|---|---|
| France | 2022-01-11 | 2022-01-19 | 2024-04-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-03 | France | Acceptable 2024-11-08
|
2024-11-08 |