Naam studie – korte synopsis:
Title: A multicentre, randomised, double-blind, parallel group, placebo-controlled trial to assess the effects of oral TRPC6 inhibitor BI 764198 taken over a 104 week treatment period in adult and adolescent participants with primary focal segmental glomerulosclerosis (pFSGS) or genetic FSGS related to TRPC6 gene variants
Phase: III
Description: This multicentre trial in participants with pFSGS, or genetic FSGS resulting from TRPC6 gain-of-function gene mutations is a randomised, double-blind, placebo-controlled, parallel group design, and will compare a once daily tablet dose of BI 764198 (20 mg) with placebo, on top of standard of care, for a treatment period of 104 weeks.
The reduction of proteinuria with TRPC6 inhibition by BI 764198 is anticipated to provide a substantial benefit to participants and a novel therapeutic approach in the management and progression of pFSGS. Therefore, the continued investigation of this novel mode of action in pFSGS and genetic FSGS resulting from TRPC6 gain-of-function gene mutations in Phase III is clinically warranted.
coördinerend centrum/contact*:
UZ Leuven : PI - Björn Meijers
overige deelnemende centra**:AZORG: Bruno Van Vlem
*: te contacteren wanneer uw centrum wil deelnemen aan de studie en patiënten rechtstreeks wil includeren
**: te contacteren wanneer u zelf niet wil deelnemen maar wel een patiënt wil doorverwijzen naar dichtstbijzijnde includerende centrum
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