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

Résumé

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.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   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)

   Délai Baseline and Week 104

2. Critère de jugement secondaire

   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)

   Délai Baseline and Week 104

3. Critère de jugement secondaire

   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)

   Délai At Week 104

4. Critère de jugement secondaire

   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.

   Délai At Week 104

5. Critère de jugement secondaire

   Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104

   24-hour urinary protein-to-creatinine ratio (24-hr UPCR)

   Délai At Week 104

6. Critère de jugement secondaire

   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.

   Délai Baseline and Week 104

7. Critère de jugement secondaire

   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.

   Délai Baseline and Week 104

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

197 sites sont en recrutement

257 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

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