Nephrology Consultants LLC | Huntsville, AL
Status and phase
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Study type
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Identifiers
About
This study is open to adults with a type of kidney disease called 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.
Enrollment
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Inclusion and exclusion criteria
Inclusion criteria:
Further inclusion criteria apply.
Exclusion critaria:
Further exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
60 participants in 4 patient groups, including a placebo group
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Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
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