A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT07220083
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS.
Participants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine.
Participants take a tablet once a day for up to 2 years. All participants also continue their standard medication for FSGS.
Participants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 286
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 764198 treatment BI 764198 - Placebo treatment Placebo -
- Primary Outcome Measures
Name Time Method Relative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104 Baseline and Week 104
- Secondary Outcome Measures
Name Time Method Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104 Baseline and Week 104 Estimated glomerular filtration rate based on serum cystatin C (eGFRcys)
Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104 At Week 104 24-hour urinary protein-to-creatinine ratio (24-hr UPCR)
Treatment response, defined as 24-hr UPCR <1000 mg/g and eGFRcys ≥85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint) At Week 104 24-hour urinary protein-to-creatinine ratio (24-hr UPCR), Estimated glomerular filtration rate based on serum cystatin C (eGFRcys).
Treatment failure defined as one or more of the following:
* Use of rescue therapy due to worsening or severely active disease leading to the Investigator concluding that the randomised treatment regimen has failed and requires additional treatment.
* Presence of any of the following events:
* End-stage renal disease
* Receipt of a kidney transplant
* Death
* Intensification of concomitant medication used at screening. Therapies that are considered include:
* Calcineurin inhibitors
* Azathioprine
* Mycophenolate mofetil
* Glucocorticoids: Prednisolone dose escalated to a dose of ≥20 mg/d (oral or intravenous) or equivalent for more than 14 days for treatment of kidney diseaseComplete remission, defined as 24-hr UPCR <300 mg/g at Week 104 At Week 104 24-hour urinary protein-to-creatinine ratio (24-hr UPCR)
Change from baseline across disease-specific clinical outcome assessment (COA) NS-SIM-PRO at Week 104 Baseline and Week 104 The nephrotic syndrome swelling impact measure (NS-SIM-PRO) has 23 items covering physical function (e.g. mobility), physical symptoms (e.g. fatigue, nausea), and essential function (e.g. vision) impacts identified as being important aspects of participants' experiences with nephrotic-syndrome related swelling.
It is expected that all item responses will be combined to generate a single score representing overall swelling impact.
The score ranges from 0 up to 4 (0 = never, 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). A lower score on any of the NS-SIM-PRO subscales indicate a better quality of life.
The NS-SIM-PRO is applicable only for participants where the investigator confirms the participant is suffering from the symptom swelling at the time of assessment.Change from baseline across clinical outcome assessment (COA) KDQOL-36 at Week 104 Baseline and Week 104 Kidney disease quality of life 36-item short form survey (KDQOL-36) assessing the health-related quality of life (HRQOL) in adult participants with kidney disease. It combines the generic SF-12 Health Survey with additional items specifically relevant to kidney disease.
Key Components:
* SF-12 Health Survey: Includes 12 items that measure physical and mental health, providing a broad overview of the patient's general health status.
* Burden of Kidney Disease: This subscale (4 items) assesses how much kidney disease interferes with daily life and causes frustration.
* Symptoms/Problems: This subscale (12 items) evaluates the frequency and severity of symptoms related to kidney disease, such as pain, fatigue, and sleep disturbances.
* Effects of Kidney Disease: This subscale (8 items) measures the impact of kidney disease on daily activities and overall well-being.
The score ranges from 0 up to 6 and a higher score on most of the KDQOL-36 subscales indicate a better quality of life.
Trial Locations
- Locations (156)
Nephrology Consultants, LLC
🇺🇸Huntsville, Alabama, United States
Amicis Research Center - Balboa
🇺🇸Granada Hills, California, United States
Academic Medical Research Institute - Glendale
🇺🇸Los Angeles, California, United States
North America Research Institute
🇺🇸San Dimas, California, United States
Valiance Clinical Research-Tarzana-68237
🇺🇸Tarzana, California, United States
Total Research Group, LLC
🇺🇸Miami, Florida, United States
CTR Oakwater, LLC
🇺🇸Orlando, Florida, United States
Endeavor Health
🇺🇸Evanston, Illinois, United States
Northwest Louisiana Nephrology
🇺🇸Shreveport, Louisiana, United States
St. Clair Nephrology Research, LLC - Shelby Township
🇺🇸Utica, Michigan, United States
Scroll for more (146 remaining)Nephrology Consultants, LLC🇺🇸Huntsville, Alabama, United StatesBoehringer IngelheimContact833-602-2368unitedstates@bitrialsupport.com