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Currently Enrolling
Interventional

FSGS Clinical Research Study

A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis (FSGS)

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

Moravia Vasallo

Email Phone 915-306-4669
Site Name

MedResearch, Inc.
1201 East Schuster Avenue, BLDG 1 A

Find other locations for this trial:
Currently Enrolling
Interventional

FSGS Clinical Research Study

A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis (FSGS)

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.

Eligibility Criteria
Patient Population

Primary FSGS or documented Transient Receptor Potential Cation subfamily C Member 6 (TRPC6) gene mutation causing FSGS.

Age

18 — 26+

History of transplant allowed?

No

History of dialysis allowed?

No

eGFR

UPCR

Permitted medication history

Ace Inhibitors/ARB, Prednisone (Steroids), None

Patient should be

Treatment Resistant, Steroid Dependent

About the Drug
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.

Sponsor

Boehringer Ingelheim Pharmaceuticals, Inc.

Estimated End Date

October 2024

About the Trial
Study Drug

BI 764198

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.

About the drug or intervention

BI 764198 is taken orally as a capsule once daily.

Find other locations for this trial:
El Paso, TX
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions