A clinical study to learn more about the safety and effects of Farabursen in people with autosomal dominant polycystic kidney disease
Descrizione riassuntiva dello studio
This clinical study investigates an experimental drug called Farabursen in adults with autosomal dominant polycystic kidney disease (ADPKD), a genetic condition where cysts form in the kidneys over time. These cysts can lead to kidney enlargement and eventually impair kidney function. The aim of the study is to determine whether Farabursen can slow the progression of the disease by reducing kidney growth and preserving kidney function. Participants will be randomly assigned to receive either Farabursen or a placebo (a treatment without an active ingredient). The study is double-blind, meaning that neither the participants nor the investigators know which treatment each participant is receiving. The treatment will be administered as a subcutaneous injection every two weeks. Participants will regularly attend study visits where health checks, laboratory tests, imaging studies (such as MRI), and questionnaires about their health status and quality of life will be conducted. The study will last approximately 2 years. The results are expected to show whether Farabursen is safe and effective as a potential new treatment for ADPKD.
(BASEC)
Intervento studiato
Participants will receive either:
• Farabursen (experimental investigational drug), or
• Placebo (an inactive comparator treatment)
Farabursen will be administered as a subcutaneous injection (under the skin) every two weeks. Two different dosing levels will be investigated. The study will compare how well Farabursen slows the progression of kidney disease compared to placebo. At the same time, safety and tolerability will also be assessed.
(BASEC)
Malattie studiate
Autosomal dominant polycystic kidney disease (ADPKD)
(BASEC)
Participants must:
1. Be adults (18 years or older) with a confirmed diagnosis of ADPKD
2. Have a risk for disease progression based on imaging (MRI) and kidney function
3. Meet certain criteria regarding kidney function (eGFR) and disease classification.
(BASEC)
Criteri di esclusione
Participants cannot participate in the study if they:
1. Have received approved treatments for ADPKD (e.g., Tolvaptan) within three months prior to screening.
2. Have previously received Farabursen or participated in another Farabursen study.
3. Have other serious kidney diseases or severe medical conditions that could affect the study outcomes.
(BASEC)
Luogo dello studio
Basilea, Berna, Losanna, Zurigo
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Medizinische Auskünfte
Tel: +41 800 633 463
swiss.medinfo@clutternovartis.comNovartis Pharma Schweiz AG Medical Information
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
06.10.2026
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Autosomal Dominant Polycystic Kidney Disease to Evaluate the Efficacy and Safety of Farabursen (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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