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A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

Study acronym: FIONA
StatusActive, Not Recruiting
PhasePhase 3
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv43
  2. Minor Enrollment closed, study ongoing Trial sites reduced: 164 → 132 locations · Primary completion moved earlier from May 31, 2027 to Apr 10, 2027 · Completion moved earlier from Jun 30, 2027 to May 10, 2027v42 Show 3 more changesShow less
    • Trial sites reduced: 164 → 132 locations
    • Primary completion moved earlier from May 31, 2027 to Apr 10, 2027
    • Completion moved earlier from Jun 30, 2027 to May 10, 2027
  3. Minor Primary completion moved earlier from Jul 31, 2027 to May 31, 2027 Completion moved earlier from Aug 31, 2027 to Jun 30, 2027 · Study sites revised (164)v41 Show 2 more changesShow less
    • Completion moved earlier from Aug 31, 2027 to Jun 30, 2027
    • Study sites revised (164)

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Trial sites expanded: 154 → 164 locationsv40
  5. Notable Primary endpoint revised Study sites: 164 to 154 · Secondary endpoints revised (10)v39 Show 2 more changesShow less
    • Study sites: 164 to 154
    • Secondary endpoints revised (10)

    See this version in full on ClinicalTrials.gov ↗

Show 37 earlier versionsHide 37 earlier versions
  1. Minor Study sites: 163 to 164v38
  2. Minor Study sites: 154 to 163v37
  3. Minor Study sites: 163 to 154v36
  4. Minor Study sites revised (163)v35 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites: 156 to 163v34
  6. Minor Study sites: 146 to 156v33
  7. Minor Study sites: 142 to 146v32
  8. Minor Study sites: 128 to 142v31
  9. Minor Study sites: 114 to 128 Primary completion date: Feb 11, 2027 to Jul 31, 2027 · Completion date: Mar 11, 2027 to Aug 31, 2027v30 Show 2 more changesShow less
    • Primary completion date: Feb 11, 2027 to Jul 31, 2027
    • Completion date: Mar 11, 2027 to Aug 31, 2027
  10. Minor Study sites: 150 to 114 Eligibility criteria expanded, about 18 wordsv29 Show 1 more changeShow less
    • Eligibility criteria expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  11. Minor Study sites: 148 to 150v28
  12. Minor Study sites: 147 to 148v27
  13. Minor Study sites: 145 to 147v26
  14. Minor Study sites revised (145)v25 See this version in full on ClinicalTrials.gov ↗
  15. Minor Site details revised at 3 of 145 sitesv24
  16. Minor Study sites revised (145)v23 See this version in full on ClinicalTrials.gov ↗
  17. Minor Site details revised at 2 of 145 sitesv22
  18. Minor Study sites: 144 to 145v21
  19. Minor Study sites: 142 to 144v20
  20. Minor Site details revised at 3 of 142 sitesv19
  21. Minor Study sites revised (142)v18 See this version in full on ClinicalTrials.gov ↗
  22. Minor Study sites: 138 to 142v17
  23. Minor Study sites: 128 to 138 Eligibility criteria revisedv16 Show 1 more changeShow less
  24. Minor Study sites: 127 to 128v15
  25. Minor Site details revised at 5 of 127 sitesv14
  26. Notable Primary completion date: Aug 12, 2026 to Feb 11, 2027 Study sites: 125 to 127 · Completion date: Sep 11, 2026 to Mar 11, 2027v13 Show 2 more changesShow less
    • Study sites: 125 to 127
    • Completion date: Sep 11, 2026 to Mar 11, 2027
  27. Minor Study sites revised (125)v12 See this version in full on ClinicalTrials.gov ↗
  28. Minor Study sites: 124 to 125v11
  29. Minor Study sites: 123 to 124v10
  30. Minor Study sites: 122 to 123v9
  31. Minor Study sites revised (122)v8 See this version in full on ClinicalTrials.gov ↗
  32. Minor Site details revised at 7 of 122 sitesv7
  33. Minor Study sites: 121 to 122 Eligibility criteria expanded, about 47 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 47 words

    See this version in full on ClinicalTrials.gov ↗

  34. Minor Study sites: 119 to 121v5
  35. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 116 to 119 · Primary completion date: Jul 18, 2026 to Aug 12, 2026 · Completion date: Aug 17, 2026 to Sep 11, 2026 · 1 morev4 Show 4 more changesShow less
    • Study sites: 116 to 119
    • Primary completion date: Jul 18, 2026 to Aug 12, 2026
    • Completion date: Aug 17, 2026 to Sep 11, 2026
    • Start date changed from estimate of Feb 25, 2022 to Mar 28, 2022
  36. Minor Study sites: 111 to 116 Primary completion date: Jun 27, 2026 to Jul 18, 2026 · Completion date: Jul 27, 2026 to Aug 17, 2026 · Start date: Jan 28, 2022 to Feb 25, 2022v3 Show 3 more changesShow less
    • Primary completion date: Jun 27, 2026 to Jul 18, 2026
    • Completion date: Jul 27, 2026 to Aug 17, 2026
    • Start date: Jan 28, 2022 to Feb 25, 2022
  37. Minor Study sites: 24 to 111 Start date: Jan 19, 2022 to Jan 28, 2022v2 Show 1 more changeShow less
    • Start date: Jan 19, 2022 to Jan 28, 2022
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
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Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can stop the kidneys from working properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications. To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests. This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take: * either finerenone or the placebo, in addition to * either ACEI or ARB, whichever they take as part of their normal treatment Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants will: * have their blood pressure, heart rate, temperature, height and weight measured * have blood and urine samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) * answer questions about their medication and whether they have any adverse events , or have their parents or guardians answer * answer questions about how they are feeling, or have their parents or guardians answer * answer question about how they like the study medication, or have their parents or guardians answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.
Trial Details
NCT Number NCT05196035
Lead Sponsor Bayer
Conditions Chronic Kidney Disease, Proteinuria
Enrollment 219 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov