Chronic kidney disease Proteinuria MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1 Level: PT Classification code 10037032 Term: Proteinuria System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be 6 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Planned urological surgery expected to influence renal function 2. Children with hemolytic uremic syndrome diagnosed =6 months prior to screening 3. Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening 4. Scheduled renal transplant within the next 6 months 5. Renal allograft in place 6. Bilateral renal artery stenosis 7. Acute kidney injury requiring dialysis within 6 months prior to screening 8. Patients with genetically defined primary tubulopathies leading to tubular proteinuria, such as Dent´s disease 9. Systemic hypertension stage 2 in children =1 year of age defined according to institutional guidelines on blood pressure management at screening or randomization 10. SBP above 110 mmHg in infants 6 months to <1 year of age at screening or randomization 11. Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they must be excluded if their SBP is <80 mmHg). 12. Known hypersensitivity to the study treatment (active substance or excipients) 13. Addison’s disease 14. Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores 15. Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids, within <6 months prior to screening for any reason 16. Concomitant therapy with an MRA (eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any SGLT2 inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene) which cannot be discontinued at least 30 days prior to the screening visit 17. Concomitant therapy with both ACEI and ARBs in case one of those cannot be discontinued at least 30 days prior to the screening visit 18. Concomitant therapy with potent CYP3A4 inhibitors, moderate or potent CYP3A4 inducers and/or the moderate CYP3A4 inhibitor erythromycin (to be stopped at least 7 days before randomization) 19. Previous assignment to treatment during this study 20. Simultaneous participation in another interventional clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to Run-in visit 21. Any other condition or therapy, which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 6 months) 22. Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the investigator affect compliance with study requirements 23. Pregnant or breast-feeding or intention to become pregnant during the study 24. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that finerenone in addition to an ACEI or ARB is superior to placebo in reducing urine protein excretion;Secondary Objective: Secondary objectives are: To assess the safety profile of finerenone in addition to SoC in pediatric CKD patients compared to placebo To further support the efficacy of finerenone in addition to SoC compared to placebo To confirm the dose and systemic exposure of finerenone in CKD patients To assess the acceptability and palatability of the age-appropriate pediatric formulation;Primary end point(s): Mean reduction from baseline to Month 6 in Urinary Protein-to-Creatinine Ratio (Percent change from baseline to day 180±7 in UPCR);Timepoint(s) of evaluation of this end point: From baseline to day 180±7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of participants with a. Adverse Events (AEs) b. Serious Treatment Emergent Adverse Events (TEAEs) c. TEAEs and serious TEAEs leading to discontinuation of treatment d. Study drug related TEAEs and serious TEAEs e. TEAEs categorized by severity (mild, moderate, severe) f. TEAEs by maximum intensity g. Number of participants hospitalized with hyperkalemia h. Number of participants discontinuing due to hyperkalemia i. Number of participants hospitalization for worsening of renal function j. Number of participants discontinuing due to worsening of renal function 2. Change in serum potassium levels, serum creatinine, eGFR and systolic blood pressure from baseline to day 180±7 3. Urinary Protein-to-Creatinine Ratio (UPCR) reduction of at least 30% from baseline to day 180±7 (Proportion of responders at the day 180±7 time point, where a responder is defined as a >=30% reduction in UPCR compared to baseline 4. Change in UACR from baseline to day 180±7 5. PK (finerenone Cmax,md, AUCt,md) based on total concentrations in plasma 6. Taste and texture of the pediatric formulation;Timepoint(s) of evaluation of this end point: 1. From the start of study intervention to last follow-up visit (last study intervention + 3 days) 2. From baseline to day 180±7 3. From baseline to day 180±7 4. From baseline to day 180±7 5. From baseline to day 180±7 6. From baseline to day 180±7 | — |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed