Status:
RECRUITING
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
Lead Sponsor:
Bayer
Conditions:
Chronic Kidney Disease
Proteinuria
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
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 prote...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT05196035
Start Date
March 28 2022
End Date
August 31 2027
Last Update
September 17 2025
Active Locations (163)
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1
Phoenix Children's Hospital | Main - Transplant Department
Phoenix, Arizona, United States, 85016
2
Cedars-Sinai Medical Center - Nephrology
Los Angeles, California, United States, 90048
3
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Palo Alto, California, United States, 94304
4
Rady Children's Hospital San Diego - Cardiology
San Diego, California, United States, 92123