Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
30
Countries
1
Sites
7
Kidney trasplants
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Trial duration
- 17 Apr 2026 → ongoing
- Decision date (initial)
- 2025-05-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Kidney trasplants
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10023438 | Kidney transplant | 10042613 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Dr Fritz Diekmann
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Dr Fritz Diekmann
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 30 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Fundacio Puigvert
Nephrology, Calle De Cartagena 340-350, 08025, Barcelona
Hospital Clinic De Barcelona
Nephrology and Kidney Transplantation, Calle Villarroel 170, 08036, Barcelona
Hospital Germans Trias I Pujol
KIDNEY AND PANCREAS TRASPLANT UNIT, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Miguel Servet
Nephrology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitari Vall D Hebron
Nephrology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Bellvitge University Hospital
Nephrology and Renal Transplantation, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital Del Mar
Nephrology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
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 |
|---|---|---|---|---|---|
| Spain | 2025-06-25 | 2025-06-25 | 2025-12-31 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-114958
- Halt date
- 2025-12-31
- Planned restart
- 2026-02-20
- Member states concerned
- Spain
- Publication date
- 2026-01-15
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- After the notification of the exitus of two patients who had received study treatment the study was halted (recruitment and treatment). The Sponsor considers it appropriate to perform a safety analysis before administration of the investigational product to any additional patients.
- Follow-up measures
- Apart from the two cases with fatal outcomes, no other patient enrolled in the study has received the treatment to date. In the event that a transplant alarm is triggered for a patient already enrolled in the clinical trial, it is proposed that the transplant be performed in accordance with the center’s standard clinical criteria; however, the investigational product would not be administered.
A DSMB meeting will be convened as soon as possible in order to evaluate the events. Clinical
information about the patients and all safety information will be provided for the meeting. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-13 | Spain | Acceptable 2025-05-05
|
2025-05-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-19 | Spain | Acceptable | 2026-04-16 |