A Phase 3 interventional study of BI 764198 and Placebo in Focal Segmental Glomerulosclerosis, sponsored by Boehringer Ingelheim. Recruiting at 315 sites in 40 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
PODOMOUNT-pFSGS
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.
105 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 33 are open to participants now.
This study's planned enrollment of 286 is above the median of 30 across 73 interventional studies indexed under Glomerulosclerosis, Focal Segmental.
Browse Glomerulosclerosis, Focal Segmental studies →Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with a diagnosis prior to the screening visit (Visit 1) of either:
Estimated (eGFR)
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BI 764198
Drug: Placebo
BI 764198
Also known as: Apecotrep
Placebo matching BI 764198
Relative change in 24-hour UPCR (measured in mg/g) from baseline to Week 104
24-hour urinary protein-to-creatinine ratio (24-hr UPCR)
Time frame: Baseline and Week 104
Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104
Estimated glomerular filtration rate based on serum cystatin C (eGFRcys)
Time frame: Baseline and Week 104
Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104
24-hour urinary protein-to-creatinine ratio (24-hr UPCR)
Time frame: At Week 104
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)
Treatment failure defined as one or more of the following: * Use of rescue therapy (treatment escalation) * worsening or severely active disease is defined when the Investigator determines that the randomised treatment regimen has failed and requires treatment escalation newly introduced during the trial (treatment escalation means either initiation of a new medication, or increasing the dose, or target peak or trough level of selected co-medications). * intensification of immunosuppressive medications used at screening. Therapies that are considered include: * calcineurin inhibitors * azathioprine, mycophenolate mofetil * cyclophosphamide, chlorambucil * 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 disease * Presence of any of the events: * End-stage kidney disease (defined as initiation of chronic renal replacement therapy or receipt of a kidney transplant) * Death
Time frame: At Week 104
Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104
24-hour urinary protein-to-creatinine ratio (24-hr UPCR)
Time frame: At Week 104
Change from baseline across disease-specific clinical outcome assessment (COA) NS-SIM-PRO at 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.
Time frame: Baseline and Week 104
Change from baseline across clinical outcome assessment (COA) KDQOL-36 at 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.
Time frame: Baseline and Week 104
Showing the first 100 of 315 sites across 40 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access criteria: For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor'spublication plan); 2. and upon signing of a legal agreement.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
Started Feb 2026 (actual). Primary completion is estimated for Dec 2028, 34 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: BI-764198
Glomerulosclerosis, Focal Segmental →