PoCP study in FSGS
Research type
Research Study
Full title
A multicenter, randomized, double-blind, parallel group, placebo controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis
IRAS ID
1005130
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2020-000384-23
Clinicaltrials.gov Identifier
Research summary
This study is open to adults with a type of kidney disease called primary focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in people with FSGS. Three different doses of
BI 764198 are tested in this study. Participants are put into 4 groups randomly, which means by chance. Three of the groups receive
different doses of BI 764198 and one group receives placebo. Participants are in the study for about 4 months. For about 3 months, they take BI 764198 or placebo as capsules once a day.Placebo capsules look like BI 764198 capsules but do not contain any medicine. Participants visit the study site about 10 times. You can participate in this study from your home. In this case a research nurse will visit you for the study visits. Kidney health is assessed based on the analysis of urine samples, which participants collect at home. At the end of the study, the results are compared between the different groups. During the study, the doctors also regularly check the general health of the participants.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/LO/0481
Date of REC Opinion
2 Sep 2022
REC opinion
Further Information Favourable Opinion