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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed
Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as
* CKD stages 1-3 (eGFR ≥30 mL/min/1.73m\^2) for children ≥1 year to \<18 years of age or
* a serum creatinine ≤ 0.40 mg/dL for infants 6 months to \< 1 year of age and
* severely increased proteinuria as defined by
* Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or
* UPCR ≥ 1.0 g/g for patients \< 2 years of age or ≥ 2 years of age and with CKD stage 1
Participants must have stable kidney function between screening and D0 defined as:
* For participants with a creatinine of \> 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0
* For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.
Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening
K+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children \<2 years of age at both screening and D0
You may not be if
Planned urological surgery expected to influence renal function
Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
Renal allograft in place
Bilateral renal artery stenosis
Acute kidney injury requiring dialysis within 6 months prior to screening
Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization
Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to \<1 year of age at screening or randomization
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)
Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within \<6 months prior to screening
Clareo Health | 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
