Chronic Kidney Disease
Conditions
Keywords
kidney disease, albuminuria, Finerenone
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.
Detailed description
FINE-START is a multicenter, international, randomized, placebo-controlled, double blind parallel-group Phase 3 study in adult participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors. The study will enroll adults (≥18 years) with CKD defined as eGFR ≥25 and \<120 mL/min/1.73 m2, urinary albumin-to-creatinine ratio (UACR) ≥100 mg/g (11.3 mg/mmol) to \<5000 mg/g (565 mg/mmol) and documentation of elevated albuminuria or proteinuria. A total of 180 participants will be included and randomized with equal allocation (1:1) to Finerenone or placebo. Finerenone or placebo will be administered once daily for approximately 6 months. Change in UACR from baseline over 6 months will be used as a primary endpoint to demonstrate slowing of kidney disease progression. The aim of this study is 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.
Interventions
Finerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors
DRUGPlacebo
Placebo matching finerenone
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
parallel-group, randomized, prospective, interventional, double-blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary albumin-to-creatinine ratio (UACR) | Baseline upto 6 months | Change in UACR from baseline (ratio to baseline) over 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TEAEs, TESAEs | Baseline upto 6 months | Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) |
| Number of participants with Hyperkalemia | Baseline upto 6 months | Number of participants with Hyperkalemia (adverse event of special interest, AESI) |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORHiddo J. Lambers Heerspink, Prof. Dr.
University Medical Center Groningen
Outcome results
None listed