Title: PODOMOUNT-Basket, a
Phase II, multicentre, randomised, 2-arm parallel-group, double-blind,
placebo-controlled basket trial to assess safety, tolerability, PK, and
efficacy of BI 764198 in four proteinuric kidney diseases
Phase: II
Description: This multicentre, randomised,
2-arm, parallel-group, double-blind, placebo-controlled basket
trial, will
be conducted in proteinuric kidney diseases with predominant podocyte-related
pathology.
The study aims to evaluate safety, tolerability, PK, and efficacy (as
proteinuria-lowering
effects) in participants with sFSGS, TR-pMCD, Alport Syndrome, and
TR-pMN
(i.e., four disease cohorts that comprise four baskets) who are at increased
risk of
disease
progression. For these diseases, there is scientific evidence for TRPC6
dysregulation
contributing
to disease pathophysiology and progression.
This
double-blind, placebo-controlled basket trial will compare a once daily dose of
BI 764198
(20 mg) with placebo, on top of SoC, for a treatment period of 20 weeks.
The arms
for recruitment of Alport Syndrom and sFSGS have been closed already. However,
recruitment for TR-pMCD and TR-pMN is still ongoing and patient can still be
enrolled.
Contact details:
UZ Leuven : Dr
Björn Meijers
Az Maria Middelares Gent : Dr Liesbeth De Waele
AZORG : Dr Bruno Van Vlem
Health Care Professional (HCP)- and patient facing websites for the PODOMOUNT
trials can be accessed via this link: Podomount HCP Website
The bottom of the "Home" page contains a
link that HCPs can use to share the webpage with colleagues, to raise awareness
(it will open an email template that can be used for this Meer informatie beschikbaar voor leden
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