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[4-(6-Aminopyridazin-3-Yl)Piperidin-1-Yl][5-(4-Fluorophenoxy)-4-Methoxypyridin-2-Yl]Methanone

This article explores the ongoing clinical trials of BI 764198, a novel drug being investigated for the treatment of focal segmental glomerulosclerosis (FSGS), a type of kidney disease. The trials aim to assess the efficacy, safety, and tolerability of BI 764198 in patients with FSGS, as well as its pharmacokinetic and pharmacodynamic profile. This research could potentially lead to a new treatment option for individuals suffering from this challenging kidney condition.

Table of Contents

What is BI 764198?

BI 764198 is a new experimental medication being developed to treat a specific kidney disease called focal segmental glomerulosclerosis (FSGS). Its chemical name is [4-(6-aminopyridazin-3-yl)piperidin-1-yl][5-(4-fluorophenoxy)-4-methoxypyridin-2-yl]methanone.[1] This medication is currently undergoing clinical trials to assess its effectiveness and safety in patients with FSGS.

Target Condition: Focal Segmental Glomerulosclerosis (FSGS)

Focal segmental glomerulosclerosis (FSGS) is a serious kidney disease that affects the glomeruli, which are tiny filtering units in the kidneys. In FSGS, scar tissue develops in parts of the glomeruli, impairing their ability to filter blood properly. This leads to a condition called proteinuria, where excessive amounts of protein leak into the urine.[1]

Clinical Trial Details

A clinical trial is currently underway to evaluate BI 764198. This trial is described as a “multicenter, randomized, double-blind, parallel group, placebo-controlled study.” Here are some key details about the trial:[1]

  • Duration: 12 weeks
  • Main objective: To explore the efficacy of BI 764198 in reducing proteinuria (excess protein in urine)
  • Secondary objectives: To investigate the pharmacokinetic profile of BI 764198 (how the drug moves through the body)

How BI 764198 Works

While the exact mechanism of action is not fully described in the trial information, BI 764198 is likely designed to target the underlying causes of FSGS or to help reduce proteinuria. The medication is being tested to see if it can effectively lower the amount of protein in the urine of patients with FSGS.[1]

Potential Benefits

The main potential benefit being investigated is the reduction of proteinuria. The primary endpoint of the study is to determine the number of patients who achieve at least a 25% reduction in their urine protein-creatinine ratio (UPCR) after 12 weeks of treatment. This could potentially indicate an improvement in kidney function and a slowing of disease progression.[1]

Eligibility Criteria

The trial has specific criteria for who can participate. Some key inclusion criteria are:[1]

  • Adults aged 18 to 75 years
  • Diagnosed with biopsy-proven primary FSGS or documented TRPC6 gene mutation causing FSGS
  • High levels of protein in the urine (UPCR ≥ 1000 mg/g)
  • Stable doses of certain medications (if applicable), such as corticosteroids, ACE inhibitors, or ARBs

There are also several exclusion criteria, including certain other kidney conditions, uncontrolled high blood pressure, and use of specific medications.

Administration and Dosage

BI 764198 is administered as an oral capsule. The exact dosage is not specified in the trial information, but it is designed to be taken once daily for the 12-week study period.[1]

Safety Considerations

As with any new medication, safety is a crucial aspect being studied in this trial. The researchers will be monitoring for any side effects or adverse reactions throughout the study period. It’s important to note that as an experimental drug, not all potential risks are known at this stage.[1]

Patients considering participation in this or any clinical trial should discuss the potential risks and benefits thoroughly with their healthcare provider.

Aspect Details
Drug Name BI 764198
Condition Studied Focal Segmental Glomerulosclerosis (FSGS)
Study Design Multicenter, randomized, double-blind, placebo-controlled
Treatment Duration 12 weeks
Primary Endpoint 25% reduction in 24-hour urine protein-creatinine ratio (UPCR) at week 12
Key Inclusion Criteria Adults 18-75 years, biopsy-proven FSGS or TRPC6 mutation, UPCR ≥ 1000 mg/g
Key Exclusion Criteria Secondary FSGS, organ transplantation, uncontrolled hypertension
Dosage Form Oral capsule
Frequency Once daily

FAQ

  • What is BI 764198? BI 764198 is an experimental drug being tested for the treatment of focal segmental glomerulosclerosis (FSGS), a type of kidney disease. It is taken orally once daily and is being studied to see if it can help reduce protein in the urine, which is a common problem in FSGS.
  • Who can participate in this clinical trial? The trial is open to men and women aged 18 to 75 years who have been diagnosed with primary FSGS through a biopsy or have a documented TRPC6 gene mutation causing FSGS. Participants must also have a certain level of protein in their urine and meet other specific criteria.
  • How long does the clinical trial last? The main treatment period of the trial lasts for 12 weeks, during which participants take BI 764198 or a placebo once daily. There is also a follow-up period after the treatment ends.
  • What are the main goals of this clinical trial? The primary goal is to see if BI 764198 can reduce the amount of protein in the urine by at least 25% after 12 weeks of treatment. The trial also aims to study how the drug behaves in the body and assess its safety and tolerability.
  • Are there any restrictions on medications during the trial? Yes, there are some restrictions. Participants must be on stable doses of certain medications (like corticosteroids or blood pressure medications) for at least 4 weeks before the trial. Some medications, such as calcineurin inhibitors or certain cancer treatments, are not allowed within a specific time frame before the trial starts.

Ongoing Clinical Trials on [4-(6-Aminopyridazin-3-Yl)Piperidin-1-Yl][5-(4-Fluorophenoxy)-4-Methoxypyridin-2-Yl]Methanone

  • BI 764198 in Adults and Adolescents with Proteinuric Kidney Diseases

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia Denmark Estonia France Germany +10

  • A study to evaluate the effects of BI 764198 in adults and adolescents with focal segmental glomerulosclerosis (FSGS)

    Recruiting

    3 1
    Investigated drugs:
    Belgium Croatia Denmark France Germany Greece +9

  • Study of BI 764198 for Patients with Focal Segmental Glomerulosclerosis

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Spain

Glossary

  • Focal Segmental Glomerulosclerosis (FSGS): A type of kidney disease that affects the glomeruli (tiny filtering units in the kidneys) and causes scarring. This can lead to protein leakage into the urine and eventual kidney failure.
  • Proteinuria: The presence of excess protein in the urine, which is a sign of kidney damage or disease.
  • Urine Protein-Creatinine Ratio (UPCR): A test that measures the amount of protein in the urine relative to creatinine, used to assess kidney function and detect kidney disease.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Pharmacodynamics: The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Placebo: An inactive substance that looks like the drug being tested but has no therapeutic effect, used as a control in clinical trials.
  • TRPC6 Gene Mutation: A genetic alteration in the Transient Receptor Potential Cation Channel Subfamily C Member 6 gene, which can cause some forms of FSGS.
  • Biopsy: A medical procedure where a small sample of tissue is taken from the body for examination, used to diagnose FSGS by looking at kidney tissue under a microscope.
  • Steady State: The condition where the amount of drug in the body remains constant, typically reached after multiple doses of medication.

References

  1. http://clinicaltrials.eu/trial/56722/