PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites reduced: 164 → 159 locations
  2. Study sites revised (164)
  3. Study sites: 163 to 164
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 3 entries
  4. Study sites revised (163)v20
  5. Study sites: 161 to 163v19
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  1. Study sites revised (161)v18
  2. Study sites revised (161)v17
  3. Study sites revised (161)v16
  1. Trial sites expanded: 157 → 161 locationsv15
  2. Study sites: 156 to 157v14
  3. Study sites: 155 to 156v13
  4. Trial sites expanded: 148 → 155 locationsv12
  5. Site details revised at 1 of 148 sitesv11
  6. Study sites: 147 to 148
    • Primary completion date: Dec 24, 2027 to Jan 20, 2028
    • Study completion date: Jan 21, 2028 to Feb 17, 2028
    v10
  7. Study sites: 148 to 147v9
  8. Trial sites expanded: 145 → 148 locationsv8
  9. Recruitment opened
    • Trial sites expanded: 140 → 145 locations
    • Start date changed from estimate of Mar 18, 2026 to Mar 23, 2026
    v7
  10. Study sites: 132 to 140
    • Start date: Mar 10, 2026 to Mar 18, 2026
    v6
  11. Study sites: 128 to 132
    • Start date: Feb 24, 2026 to Mar 10, 2026
    v5
  12. Study sites: 120 to 128v4
  13. Study sites: 118 to 120v3
  14. Enrollment target: 60 to 132
    • Study sites: 58 to 118
    v2
  15. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. 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 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. 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.
Trial Details
NCT Number NCT07355296
Lead Sponsor Boehringer Ingelheim
Conditions
(from sponsor)		 Proteinuric Kidney Diseases
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov