Short title: 20186 FIONA OLE Finerenone for the treatment of children with chronic nephropathy and proteinuria
Summary description of the study
Open-label extension study of 19920-FIONA The aim of this study is to continue observing the safety and examine the efficacy of finerenone (investigational drug) in children with chronic kidney dysfunction (CKD) and proteinuria (protein excretion in urine) in addition to their standard treatment. The study also focuses on the absorption of the investigational drug, its distribution in the body, and how it is eliminated.
(BASEC)
Intervention under investigation
Open-label administration of finerenone.
Participants who have completed their treatment in the FIONA study will receive finerenone.
(BASEC)
Disease under investigation
Chronic nephropathy and proteinuria in children aged 1 year to < 18 years
(BASEC)
Patients must have completed treatment in 19920-FIONA. 1-Participants must be aged 1 year to < 18 years at the time of signing the informed consent/assent. 2. At the time of selection, participants must have a clinical diagnosis of chronic kidney disease and be sufficiently stable. 3. Treatment with ACE inhibitors or ARBs at stable doses. (BASEC)
Exclusion criteria
1. Planned urological surgery that may influence renal function. 2. Children with hemolytic uremic syndrome (HUS) diagnosed ≤ 6 months prior to selection. 3. Patients with nephrotic syndrome receiving albumin infusions in the 6 months prior to selection. 4. Planned kidney transplantation within the next 6 months. (BASEC)
Trial sites
Basel, Geneva, Lausanne
(BASEC)
Sponsor
Bayer AG
(BASEC)
Contact
Contact Person Switzerland
Sophia Birnbaum
+41 44 4658111
clinical.operations.switzerland@clutterbayer.comBayer Schweiz AG
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
27.10.2022
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
An 18-month, open-label, single-arm safety extension study of an age-and bodyweightadjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available