PIONEER-PKD
Research type
Research Study
Full title
A Phase I Randomised, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1613 Following Multiple Ascending Dose Administration in Participants with Autosomal Dominant Polycystic Kidney Disease
IRAS ID
1012607
Contact name
Roser Sanz Casañas
Contact email
Sponsor organisation
ASTRAZENECA FARMACÉUTICA SPAIN, S.A
Research summary
This study is being conducted to learn more about an experimental drug called AZD1613 in participants who have autosomal dominant polycystic kidney disease (ADPKD), and also to better understand ADPKD and associated health problems. AZD1613 is expected to slow the progression of cyst formation and the decline in kidney function.
This study will evaluate AZD1613 in comparison with placebo. Participants will take part in the study for about 33 weeks and will have up to 17 visits. Each visit may be different in length, from a short visit of around 1 hour to around 4 days, including overnight stays.
About 40 patients will take part in this study globally including at 1 hospital in the UK.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0287
Date of REC Opinion
14 Nov 2025
REC opinion
Further Information Favourable Opinion