Finerenone (BAY 94-8862): Finerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors
Placebo: Placebo matching finerenone
Study summary
Study to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Main Inclusion Criteria:
1. Adults (≥18 years) with Chronic Kidney Disease defined as:
* eGFR ≥25 and \<120 mL/min/1.73 m2 using CKD-EPI 2009 formula at the Screening visit.
* UACR ≥100 mg/g (11.3 mg/mmol) to \<5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) and documentation of elevated albuminuria or proteinuria.
2. Potassium level ≤5.0 mmol/L at Screening (local assessment).
3. No current or previous (within 8 weeks prior to the Screening visit) treatment with RAS inhibition (ACEi, ARB, or Renin inhibitor (e.g. Aliskiren)).
Main Exclusion Criteria:
1. Participants with an HbA1c\>11%.
2. Participants with type 1 diabetes.
3. Symptomatic heart failure with reduced ejection fraction and class 1A indication for MRA treatment.
Primary outcome measure(s)
Urinary albumin-to-creatinine ratio (UACR) — Baseline upto 6 months Change in UACR from baseline (ratio to baseline) over 6 months
Trial sites (8)
Facility
City
Region
Status
Hospital Universitari Germans Trias i Pujol
Barcelona
Spain
Vall d'Hebron University Hospital
Barcelona
Spain
Clínica Universidad de Navarra
Madrid
Spain
Hospital Universitario de La Princesa
Madrid
Spain
Hospital Universitario Puerta de Hierro
Madrid
Spain
Clínica Universidad de Navarra
Pamplona
Spain
Hospital Clinico Universitario de Valencia
Valencia
Spain
Hospital Universitario Dr Peset
Valencia
Spain
More University Medical Center Groningen trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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