Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
84
Countries
5
Sites
15
Kidney Disease
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 5 Aug 2025 → ongoing
- Decision date (initial)
- 2025-05-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516095-15-00
- ClinicalTrials.gov
- NCT06734234
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Kidney Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10036046 | Polycystic kidney autosomal dominant | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
5 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 3 | 3 |
| France | Ongoing, recruiting | 2 | 2 |
| Germany | Ongoing, recruiting | 5 | 2 |
| Netherlands | Authorised, recruitment pending | 6 | 3 |
| Spain | Ongoing, recruiting | 5 | 5 |
| Rest of world
United Kingdom, United States, Canada
|
— | 63 | — |
Investigational sites
UZ Leuven
Nephrology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Nephrology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universiteit Gent
Nephrology, Corneel Heymanslaan 10, 9000, Gent
Assistance Publique Hopitaux De Paris
Höpital Necker, Néphrologie Dialyse Adulte, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Regional Et Universitaire De Brest
Nephrology, Renal Transplant and Hemodialysis, Boulevard Tanguy Prigent, 29200, Brest
Universitaetsklinikum Schleswig-Holstein AöR
Campus Lübeck, Medizinische Klinik 1, Ratzeburger Allee 160, 23538, Luebeck
University Hospital Cologne AöR
Innere Medizin II - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Leids Universitair Medisch Centrum (LUMC)
Kidney disease, Albinusdreef 2, 2333 ZA, Leiden
Universitair Medisch Centrum Groningen
Nefrologie, Hanzeplein 1, 9713 GZ, Groningen
Hospital Universitario 12 De Octubre
Nephrology Service, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Nephrology Service, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Nephrology Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Del Mar
Nephrology Service, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Fundacio Puigvert
Nephrology Service, Calle De Cartagena 340-350, 08025, 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 |
|---|---|---|---|---|---|
| Belgium | 2025-08-26 | 2025-08-26 | |||
| France | 2025-08-19 | 2025-08-19 | |||
| Germany | 2025-09-18 | 2025-09-18 | |||
| Spain | 2025-08-05 | 2025-08-05 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-12 | Netherlands | Acceptable 2025-04-29
|
2025-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-28 | Netherlands | Acceptable 2025-09-15
|
2025-09-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-19 | Netherlands | Acceptable 2026-03-23
|
2026-03-23 |