FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors

Официальное название

A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Participants With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Finerenone (BAY 94-8862)
  Finerenone 10 or 20mg in participants with chronic kidney disease not using renin-angiotensin-system inhibitors
• Препарат Placebo
  Placebo matching finerenone

Первичные конечные точки

• Urinary albumin-to-creatinine ratio (UACR) [Срок оценки: Baseline upto 6 months]

Вторичные конечные точки (2)

• TEAEs, TESAEs [Срок оценки: Baseline upto 6 months]
• Number of participants with Hyperkalemia [Срок оценки: Baseline upto 6 months]

Критерии участия

Main Inclusion Criteria:

• 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)).

Main Exclusion Criteria:

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 8 центров

• Hospital Universitari Germans Trias i Pujol — Barcelona
• Vall d'Hebron University Hospital — Barcelona
• Clínica Universidad de Navarra — Madrid
• Hospital Universitario de La Princesa — Madrid
• Hospital Universitario Puerta de Hierro — Madrid
• Clínica Universidad de Navarra — Pamplona
• Hospital Clinico Universitario de Valencia — Valencia
• Hospital Universitario Dr Peset — Valencia

Идентификаторы

NCT: NCT07181135 · 22817 · 2025-523075-32-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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