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Evaluating Finerenone for treating chronic kidney disease in children

A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria

Phase 3 Interventional Bayer · NCT05196035

This study is testing if the medication Finerenone can help children with chronic kidney disease and protein in their urine feel better and improve their kidney function.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment219 (estimated)
Ages6 Months to 17 Years
SexAll
SponsorBayer Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide
Locations164 sites (Phoenix, Arizona and 163 other locations)
Trial IDNCT05196035 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of Finerenone, a medication, in treating children with chronic kidney disease (CKD) and proteinuria. The study aims to understand how Finerenone interacts with other common treatments like ACE inhibitors and angiotensin receptor blockers. Participants will be closely monitored for how the drug is processed in the body and its overall impact on kidney function and protein levels in urine. The trial includes children aged 6 months to under 18 years who meet specific health criteria related to CKD.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to under 18 years diagnosed with chronic kidney disease and exhibiting proteinuria.

Not a fit: Patients with stable kidney function who do not meet the specific criteria for CKD and proteinuria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and reduce proteinuria in children with chronic kidney disease.

How similar studies have performed: Other studies have shown promise in using similar approaches for treating chronic kidney disease, but the specific use of Finerenone in this population is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Phoenix, Arizona and 163 other locations

+114 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney DiseaseProteinuria
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.