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Phase 3RecruitingInterventionalNCT07220083

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants

  • Focal Segmental Glomerulosclerosis
I want to take partRefer a patient19 sites in India · 311 worldwide

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Boehringer Ingelheim
Enrolment target
286
Started
16 February 2026
Main results due (estimated)
27 December 2028
Study ends (estimated)
24 January 2029
Allocation
Randomized
Design
Parallel
Purpose
Treatment
Masking
Quadruple (participant, care provider, investigator, outcomes assessor)
Sites
311 · 19 in India
First posted
23 October 2025
Registry updated
30 September 2026

Can you take part?

  • Aged 12 years and over.
  • Open to any sex.
  • You need the condition being studied. Healthy volunteers are not accepted.

Age groups: child, adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Read the full eligibility criteria
Inclusion criteria:

1. Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
2. Weight of ≥40 kg at the screening visit (Visit 1)
3. Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
4. Participants with a diagnosis prior to the screening visit (Visit 1) of either:

   * Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR
   * Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)
5. Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
6. Estimated glomerular filtration rate (eGFR)

   * For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)
   * For adolescent participants (12 to \<18 years): ≥25 mL/min/1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.

Exclusion criteria:

1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
2. Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)
3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
4. A history of organ transplantation or planned organ transplantation during the course of the trial
5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.

What this study is about

In the sponsor’s own words, from the registry.

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.

What participants receive

  • Experimental

    BI 764198 treatment

    Drug: BI 764198

  • Experimental

    Placebo treatment

    Drug: Placebo

Interventions

  • BI 764198Drug

    Also known as Apecotrep

  • PlaceboDrug

    Placebo matching BI 764198

What the study measures

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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: Use of rescue therapy (treatment escalation): \- Worsening or severely active disease resulting in investigator-determined treatment failure and requiring rescue therapy (treatment escalation) during the trial. Treatment escalation includes initiation of a new medication or intensification of existing therapy, including an increase in the dose or target peak/trough level of selected concomitant medications (immunosuppressive therapies). Examples of intensification of immunosuppressive therapies used at screening, include: * calcineurin inhibitors (CNIs) * anti-metabolites (azathioprine, mycophenolate mofetil) * cytotoxic agents (cyclophosphamide, chlorambucil) * glucocorticoids, including escalation of prednisolone to ≥20 mg/day (oral or intravenous), or equivalent, for \>14 days for treatment of kidney disease.

    Time frame: At Week 104

  4. 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

  5. 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

  6. 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

Who is running it

Lead sponsor
Boehringer Ingelheim
Sponsor type
Industry
Responsible party
The sponsor
Organisation
Boehringer Ingelheim
Data monitoring committee
No
US FDA-regulated drug
Yes
US FDA-regulated device
No
Sponsor's study ID
1434-0017
Other IDs
2025-522191-86-00, U1111-1326-1647, 2025

Study sites(311)

Showing 40 of 311 sites, filter to narrow it down. 213 of 311 on this study are recruiting right now, and 19 are in India. A site can stop enrolling while the study as a whole is still open.

References and data sharing

Participant data shared
Yes
What is shared
Study protocol, Sap, Csr
When
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
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.

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.

Source: ClinicalTrials.gov record NCT07220083, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental G | Trialion