NCT07181135

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
20mo left

Started Mar 2026

Geographic Reach
1 country

8 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

September 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

March 13, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

September 9, 2025

Last Update Submit

April 13, 2026

Conditions

Chronic Kidney Disease

Keywords

kidney diseasealbuminuriaFinerenone

Outcome Measures

Primary Outcomes (1)

  • Urinary albumin-to-creatinine ratio (UACR)

    Change in UACR from baseline (ratio to baseline) over 6 months

    Baseline upto 6 months

Secondary Outcomes (2)

  • TEAEs, TESAEs

    Baseline upto 6 months

  • Number of participants with Hyperkalemia

    Baseline upto 6 months

Study Arms (2)

Finerenone

EXPERIMENTAL

Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.

Drug: Finerenone (BAY 94-8862)

Placebo

PLACEBO COMPARATOR

Placebo matching Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.

Drug: Placebo

Interventions

PlaceboDRUG

Placebo matching finerenone

Placebo
Finerenone (BAY 94-8862)DRUG

Finerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors

Finerenone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Potassium level ≤5.0 mmol/L at Screening (local assessment).
  • No current or previous (within 8 weeks prior to the Screening visit) treatment with RAS inhibition (ACEi, ARB, or Renin inhibitor (e.g. Aliskiren)).

You may not qualify if:

  • Participants with an HbA1c\>11%.
  • Participants with type 1 diabetes.
  • Symptomatic heart failure with reduced ejection fraction and class 1A indication for MRA treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Location

Vall d'Hebron University Hospital

Barcelona, Spain

Location

Clínica Universidad de Navarra

Madrid, Spain

Location

Hospital Universitario de La Princesa

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Spain

Location

Clínica Universidad de Navarra

Pamplona, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Spain

Location

Hospital Universitario Dr Peset

Valencia, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney DiseasesAlbuminuria

Interventions

finerenone

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsProteinuriaUrination DisordersUrological ManifestationsSigns and Symptoms

Study Officials

  • Hiddo J. Lambers Heerspink, Prof. Dr.

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel-group, randomized, prospective, interventional, double-blind study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 18, 2025

Study Start

March 13, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(8)