Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Temporarily halted
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 | Temporarily halted | 3 | 3 |
| France | Temporarily halted | 2 | 2 |
| Germany | Temporarily halted | 5 | 2 |
| Netherlands | Temporarily halted | 6 | 3 |
| Spain | Temporarily halted | 5 | 5 |
| Rest of world
United Kingdom, Canada, United States
|
— | 63 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Nephrology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universiteit Gent
Nephrology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Nephrology, Herestraat 49, 3000, Leuven
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
University Hospital Cologne AöR
Innere Medizin II - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Schleswig-Holstein AöR
Campus Lübeck, Medizinische Klinik 1, Ratzeburger Allee 160, 23538, Luebeck
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 Fundacion Jimenez Diaz
Nephrology Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Fundacio Puigvert
Nephrology Service, Calle De Cartagena 340-350, 08025, Barcelona
Hospital Del Mar
Nephrology Service, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
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
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 | 2026-06-23 | ||
| France | 2025-08-19 | 2025-08-19 | 2026-06-23 | ||
| Germany | 2025-09-18 | 2025-09-18 | 2026-06-23 | ||
| Netherlands | 2025-11-25 | 2025-11-25 | 2026-06-23 | ||
| Spain | 2025-08-05 | 2025-08-05 | 2026-06-23 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 5 · Art. 38 CTR
Temporary halt TH-142381
- Halt date
- 2026-06-23
- Member states concerned
- Spain
- Publication date
- 2026-07-07
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- To review the cumulative safety database and to update the IB, protocol and ICF to include a new potential risk of elevated transaminases in blinded data
- Follow-up measures
- Screening, randomisation and dosing of participants has been halted. Ongoing monitoring of participants who have been dosed in this single dose study is continuing, as per protocol. The updated IB, protocol, and ICF will be submitted to the relevant authorities as a substantial amendment, in accordance with local requirements
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-142375
- Halt date
- 2026-06-23
- Member states concerned
- Belgium
- Publication date
- 2026-07-07
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- To review the cumulative safety database and to update the IB, protocol and ICF to include a new potential risk of elevated transaminases in blinded data
- Follow-up measures
- Screening, randomisation and dosing of participants has been halted. Ongoing monitoring of participants who have been dosed in this single dose study is continuing, as per protocol. The updated IB, protocol, and ICF will be submitted to the relevant authorities as a substantial amendment, in accordance with local requirements
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-142383
- Halt date
- 2026-06-23
- Member states concerned
- Netherlands
- Publication date
- 2026-07-07
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- To review the cumulative safety database and to update the IB, protocol and ICF to include a new potential risk of elevated transaminases in blinded data
- Follow-up measures
- Screening, randomisation and dosing of participants has been halted. Ongoing monitoring of participants who have been dosed in this single dose study is continuing, as per protocol. The updated IB, protocol, and ICF will be submitted to the relevant authorities as a substantial amendment, in accordance with local requirements
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-142379
- Halt date
- 2026-06-23
- Member states concerned
- Germany
- Publication date
- 2026-07-07
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- To review the cumulative safety database and to update the IB, protocol and ICF to include a new potential risk of elevated transaminases in blinded data
- Follow-up measures
- Screening, randomisation and dosing of participants has been halted. Ongoing monitoring of participants who have been dosed in this single dose study is continuing, as per protocol. The updated IB, protocol, and ICF will be submitted to the relevant authorities as a substantial amendment, in accordance with local requirements
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-142377
- Halt date
- 2026-06-23
- Member states concerned
- France
- Publication date
- 2026-07-07
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- To review the cumulative safety database and to update the IB, protocol and ICF to include a new potential risk of elevated transaminases in blinded data
- Follow-up measures
- Screening, randomisation and dosing of participants has been halted. Ongoing monitoring of participants who have been dosed in this single dose study is continuing, as per protocol. The updated IB, protocol, and ICF will be submitted to the relevant authorities as a substantial amendment, in accordance with local requirements
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
4 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 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-20 | Acceptable 2026-06-08
|
2026-06-09 |