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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
Awards & highlights

Study Summary

This trial is testing a new medication to see if it can improve kidney function in patients with primary focal segmental glomerulosclerosis (FSGS). Participants will be randomly assigned to one of four groups, three of which will receive different doses of the medication and one of which will receive a placebo. The trial will last for four months, during which participants will take the medication or placebo once daily. Kidney function will be monitored via urine samples, and general health will be monitored via regular checkups.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at week 12
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,513 Total Patients Enrolled

Media Library

BI 764198 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05213624 — Phase 2
Focal Segmental Glomerulosclerosis Research Study Groups: BI 764198 - medium dose, BI 764198 - high dose, Placebo, BI 764198 - low dose
Focal Segmental Glomerulosclerosis Clinical Trial 2023: BI 764198 Highlights & Side Effects. Trial Name: NCT05213624 — Phase 2
BI 764198 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05213624 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the requirements for taking part in this trial?

"This medical trial is recruiting 60 participants with a diagnosis of kidney illness, aged between 18 and 75. Patients must meet the following criteria: Biopsy substantiated Focal Segmental Glomerulosclerosis (FSGS) or documented Transient Receptor Potential Cation subfamily C Member 6 gene mutation causing FSGS prior to screening visit; Urine Protein-Creatinine Ratio ≥ 1500 mg/g based on two 24 hour urine samples taken 7 days apart at time of screening; Completion of initial course of corticosteroid therapy (if applicable) and if not intolerance before entry into study; Corticosteroid dosage ≤"

Answered by AI

In how many locales can participants access this experiment?

"Patients residing near Marshfield Medical Center in Wisconsin, Nephrology Consultants LLC in Alabama, and Florida Kidney Physicians in Temple Terrace, FL have the opportunity to participate this trial. Additionally, 14 other locales across the US are also participating sites."

Answered by AI

Are there age restrictions on the participants of this trial?

"This medical trial is accepting volunteers aged 18 and older, but under 75."

Answered by AI

How many people have enrolled for participation in the trial?

"Affirmative. According to clinicaltrials.gov, this research project is currently in the process of recruiting participants that it first posted about on March 10th 2022 and last updated on November 17th 2022. The study requires 60 patients from 14 different medical sites."

Answered by AI

Are new participants currently being enrolled for this experimental research?

"Affirmative. The details hosted on clinicaltrials.gov reveal that this medical research project, published on March 10th 2022 and most recently updated November 17th, is presently recruiting for 60 participants across 14 distinct sites."

Answered by AI

Has the FDA sanctioned BI 764198 for consumer use?

"BI 764198 has been assessed to be moderately safe, garnering a score of 2. This is because the trial falls under Phase 2 protocol which implies that there is some evidence validating safety but none indicating efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Test BI 764198 in People With a Type of Kidney Disease Called Primary Focal Segmental Glomerulosclerosis
2022. "A Study to Test BI 764198 in People With a Type of Kidney Disease Called Primary Focal Segmental Glomerulosclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05213624.
All > Kidney Failure
~16 spots leftby Jan 2025
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