What side effects are associated with this type of intervention?

Common treatments for Focal Segmental Glomerulosclerosis (FSGS) include immunosuppressive drugs like cyclosporine and tacrolimus, corticosteroids such as prednisone, and supportive therapies like ACE inhibitors or ARBs. Known side effects of these treatments can include increased risk of infections, hypertension, diabetes, gastrointestinal issues, and bone density loss. Corticosteroids specifically can cause weight gain, mood swings, and increased blood sugar levels. Immunosuppressive drugs may also lead to kidney toxicity and elevated liver enzymes.

What prior FDA approvals exist?

There have been limited FDA approvals specifically for the treatment of Focal Segmental Glomerulosclerosis (FSGS). Traditional treatments often include corticosteroids, immunosuppressive agents like cyclosporine, and ACE inhibitors or ARBs to manage proteinuria and hypertension. BI 764198, currently under study, aims to improve kidney health in FSGS patients, representing a novel approach compared to existing therapies. This trial explores the efficacy of different doses of BI 764198, which could potentially offer a new therapeutic option for FSGS if proven effective.

What other types of research exist?

Promising novel alternatives to BI 764198 for FSGS patients include: 1) Sparsentan, a dual endothelin receptor and angiotensin II receptor antagonist, which has shown promise in reducing proteinuria in FSGS patients. 2) Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which has demonstrated renal protective effects in various kidney diseases. 3) Rituximab, a monoclonal antibody targeting CD20, which has been used off-label with some success in FSGS. These alternatives are being actively researched and may offer new therapeutic options for FSGS patients in 2024.

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BI 764198 for Focal Segmental Glomerulosclerosis

Phase 2

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Signed and dated informed consent in accordance with ICH-GCP and local legislation prior to admission to the study.

Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 13 weeks

Summary

This trial tests if the medicine BI 764198 can improve kidney health in adults with a specific kidney disease called FSGS. Participants take the medicine regularly for a few months. Their kidney health is checked through urine samples and regular health check-ups.

Who is the study for?

Adults with primary focal segmental glomerulosclerosis (FSGS), a type of kidney disease, can join this study. Participants will be tested for their kidney health and must commit to multiple study visits or have a research nurse visit them at home.

What is being tested?

The trial is testing BI 764198, a potential new treatment for FSGS. It involves three different doses of the medication compared to a placebo, taken as capsules daily over approximately three months within the four-month study period.

What are the potential side effects?

Possible side effects are not specified here but generally could include reactions related to the digestive system, skin, blood or other organs due to medication intake. Regular health checks aim to monitor any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at week 12

Secondary study objectives

Change in 24-hour UPCR relative to baseline at week 13

Change in 24-hour UPCR relative to visit 3 at week 12

Change in 24-hour urinary protein excretion relative to baseline at week 12

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 764198 - medium doseExperimental Treatment1 Intervention

BI 764198 - medium dose

Group II: BI 764198 - low doseExperimental Treatment1 Intervention

BI 764198 - low dose

Group III: BI 764198 - high doseExperimental Treatment1 Intervention

BI 764198 - high dose

Group IV: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 764198

2019

Completed Phase 1

~200

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Focal Segmental Glomerulosclerosis (FSGS) include corticosteroids, immunosuppressive agents, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). Corticosteroids and immunosuppressive agents work by reducing inflammation and suppressing the immune system, which helps to decrease the damage to the glomeruli. ACE inhibitors and ARBs help to lower blood pressure and reduce proteinuria, which can slow the progression of kidney damage. The trial studying BI 764198 focuses on its potential to improve kidney health in FSGS patients, likely by targeting specific pathways involved in kidney function and inflammation. Understanding these mechanisms is crucial for FSGS patients as it helps in selecting the most effective treatment to manage their condition and prevent further kidney damage.