Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
FSGS Clinical Research Study
A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis (FSGS)
Brief Description
This study is being done to see if the study drug, called BI 764198, may help people with FSGS. The study drug or a placebo will be taken as a capsule by mouth one (1) time every day for about 12 weeks.
Trial Physician / Study Coordinator
Jessica Hester
EmailSite Name
Duke University Medical Center
2301 Erwin Road, Durham, NC, 27710
Sponsor
Boehringer Ingelheim Pharmaceuticals, Inc.
Study Drug
BI 764198
Estimated enrollment
60 patients globally
Estimated end date
October 2024
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
FSGS Clinical Research Study
A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis (FSGS)
Brief Description
This study is being done to see if the study drug, called BI 764198, may help people with FSGS. The study drug or a placebo will be taken as a capsule by mouth one (1) time every day for about 12 weeks.
Trial is for people with
Primary FSGS or documented Transient Receptor Potential Cation subfamily C Member 6 (TRPC6) gene mutation causing FSGS.
Study Goal
This study is being done to:
• Test different doses of the study drug, BI 764198, for safety, effectiveness, and side effects, when compared to taking a placebo, in subjects with focal segmental glomerulosclerosis (FSGS).
In this study, you will either get the active study drug, BI 764198, or a placebo.
• Test how the study drug is used by the body, and how fast or slow the study drug moves through or out of the body.
What is involved for the Patient?
Patients will be asked to allow researchers to access medical history. This trial consists of a Screening Period, a Study Drug Period, an End of Treatment Visit, and a Follow-Up Period. There are about 10 visits and 1 phone call visit to participate in the trial. The study staff or study doctor may complete the following procedures during each study visit: ECG, 24 hour urine collection (instructions/collection diary distribution), collect lab samples for safety testing (blood or urine), collect biomarker samples (blood or urine) which is optional, Pharmacokinetic (PK) samples (urine), and eye exams.
About the drug or intervention
BI 764198 is taken orally as a capsule once daily.