Clinical trial • Phase I • Rare Disease
GSK4771261 for Autosomal dominant polycystic kidney disease | Kidney disease
Phase I trial of GSK4771261 for Autosomal dominant polycystic kidney disease | Kidney disease. 63 participants.
Overview
- Trial Therapeutic Area
- Rare Disease
- Trial Disease
- Autosomal dominant polycystic kidney disease | Kidney disease
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 12-12-2024
- First CTIS Authorization Date
- 30-04-2025
Trial design
Phase I trial across 15 sites in France, Spain, Germany and others.
- Target Sample Size
- 63
Eligibility
Recruits 63 No vulnerable populations selected (isVulnerablePopulationSelected: false). No specific consent/assent handling for vulnerable groups is described..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). No specific consent/assent handling for vulnerable groups is described.
Recruitment
- Planned Sample Size
- 63
- Recruitment Window Months
- 15
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 21
France
- Earliest CTIS Part Ii Submission Date
- 13-02-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 403
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Höpital Necker, Néphrologie Dialyse Adulte
- Principal Investigator Name
- Bertrand KNEBELMANN
- Principal Investigator Email
- bertrand.knebelmann@aphp.fr
- Contact Person Name
- Bertrand KNEBELMANN
- Contact Person Email
- bertrand.knebelmann@aphp.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Nephrology, Renal Transplant and Hemodialysis
- Principal Investigator Name
- Emilie CORNEC-LE GALL
- Principal Investigator Email
- emilie.cornec.le-gall@hu-brest.fr
- Contact Person Name
- Emilie CORNEC-LE GALL
- Contact Person Email
- emilie.cornec.le-gall@hu-brest.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 31-03-2025
- Latest Decision Or Authorization Date
- 26-03-2026
- Processing Time Days
- 360
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Nephrology Service
- Principal Investigator Name
- Mª Vanessa Pérez Gómez
- Principal Investigator Email
- mvanessa@fjd.es
- Contact Person Name
- Mª Vanessa Pérez Gómez
- Contact Person Email
- mvanessa@fjd.es
- Site Name
- Fundacio Puigvert
- Department Name
- Nephrology Service
- Principal Investigator Name
- Mª Roser Torra Balcells
- Principal Investigator Email
- rtorra@fundacio-puigvert.es
- Contact Person Name
- Mª Roser Torra Balcells
- Contact Person Email
- rtorra@fundacio-puigvert.es
- Site Name
- Hospital Del Mar
- Department Name
- Nephrology Service
- Principal Investigator Name
- Melissa Pilco Teran
- Principal Investigator Email
- melissalorena.pilco.teran@hmar.cat
- Contact Person Name
- Melissa Pilco Teran
- Contact Person Email
- melissalorena.pilco.teran@hmar.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Nephrology Service
- Principal Investigator Name
- Eduardo Gutiérrez Martínez
- Principal Investigator Email
- eduardogutmat90@gmail.com
- Contact Person Name
- Eduardo Gutiérrez Martínez
- Contact Person Email
- eduardogutmat90@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Nephrology Service
- Principal Investigator Name
- Laia Sans Atxer
- Principal Investigator Email
- laia.sans@vallhebron.cat
- Contact Person Name
- Laia Sans Atxer
- Contact Person Email
- laia.sans@vallhebron.cat
Germany
- Earliest CTIS Part Ii Submission Date
- 09-04-2025
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 350
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Innere Medizin II - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
- Principal Investigator Name
- Roman-Ulrich Mueller
- Principal Investigator Email
- roman-ulrich.mueller@uk-koeln.de
- Contact Person Name
- Roman-Ulrich Mueller
- Contact Person Email
- roman-ulrich.mueller@uk-koeln.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Campus Lübeck, Medizinische Klinik 1
- Principal Investigator Name
- Figen Cakiroglu
- Principal Investigator Email
- Figen.Cakiroglu@uksh.de
- Contact Person Name
- Figen Cakiroglu
- Contact Person Email
- Figen.Cakiroglu@uksh.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-03-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 363
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Kidney disease
- Principal Investigator Name
- Siebe Spijker
- Principal Investigator Email
- h.s.spijker@lumc.nl
- Contact Person Name
- Siebe Spijker
- Contact Person Email
- h.s.spijker@lumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Nefrologie
- Principal Investigator Name
- Ron Gansevoort
- Principal Investigator Email
- r.t.gansevoort@umcg.nl
- Contact Person Name
- Ron Gansevoort
- Contact Person Email
- r.t.gansevoort@umcg.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Internal medicine
- Principal Investigator Name
- Mahdi Salih
- Principal Investigator Email
- m.salih@erasmusmc.nl
- Contact Person Name
- Mahdi Salih
- Contact Person Email
- m.salih@erasmusmc.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 02-04-2025
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 357
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Nephrology
- Principal Investigator Name
- Nathalie Demoulin
- Principal Investigator Email
- nathalie.demoulin@uclouvain.be
- Contact Person Name
- Nathalie Demoulin
- Contact Person Email
- nathalie.demoulin@uclouvain.be
- Site Name
- Universiteit Gent
- Department Name
- Nephrology
- Principal Investigator Name
- Francis Verbeke
- Principal Investigator Email
- Francis.Verbeke@UZGent.be
- Contact Person Name
- Francis Verbeke
- Contact Person Email
- Francis.Verbeke@UZGent.be
- Site Name
- UZ Leuven
- Department Name
- Nephrology
- Principal Investigator Name
- Bert Bammens
- Principal Investigator Email
- bert.bammens@uzleuven.be
- Contact Person Name
- Bert Bammens
- Contact Person Email
- bert.bammens@uzleuven.be
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- GSK4771261
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