Informazioni generali
  • Categoria della malattia Altro (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea, Berna, Losanna, Zurigo
    (BASEC)
  • Responsabile dello studio Medizinische Auskünfte swiss.medinfo@novartis.com (BASEC)
  • Fonte dati BASEC: Importato da 06.10.2026 ICTRP: N/A
  • Ultimo aggiornamento 06.10.2026 15:05
HumRes68602 | SNCTP000007130 | BASEC2026-01316

A clinical study to learn more about the safety and effects of Farabursen in people with autosomal dominant polycystic kidney disease

  • Categoria della malattia Altro (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea, Berna, Losanna, Zurigo
    (BASEC)
  • Responsabile dello studio Medizinische Auskünfte swiss.medinfo@novartis.com (BASEC)
  • Fonte dati BASEC: Importato da 06.10.2026 ICTRP: N/A
  • Ultimo aggiornamento 06.10.2026 15:05

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)

Criteri di partecipazione

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)

non disponibile

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@novartis.com

Novartis 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
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile