2025-523075-32-00招募中3 期
FINE-START; 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 11
- 主要终点
- Change in UACR from baseline (ratio to baseline) over 6 months
研究概览
简要总结
To demonstrate that finerenone is superior to placebo in reducing UACR over 6 months when compared to placebo in participants with CKD not using RAS inhibitors.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.
- •Potassium level must be ≤5.0 mmol/L at Screening (local assessment).
- •Participants with a clinical diagnosis of CKD and fulfilling both the criteria (local assessment): eGFR ≥25 and <120 mL/min/1.73 m2 using CKD-EPI 2009 formula at the Screening visit; and 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* in the participant’s medical records at least 3 months prior to Screening. * 1 quantitative or semiquantitative record documented in the participant’s medical records.
- •No current or previous (within 8 weeks prior to the Screening visit) treatment with RAS inhibition (ACEi, ARB, or Renin inhibitor (e.g. Aliskiren)).
- •Male or female
- •Capable of giving signed informed consent as described in the full protocol, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. Participants not capable of giving signed informed consent will not be enrolled into this clinical trial.
排除标准
- •Participants treated with kidney transplantation.
- •Participants with Addison’s disease.
- •Any other history, condition, therapy or uncontrolled intercurrent illness which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to less than 12 months).
- •Participants concomitantly treated with strong CYP3A4 inhibitors which cannot be discontinued and have not stopped at least 7 days prior to randomization.
- •Participants concomitantly treated with moderate/strong CYP3A4 inducers which cannot be discontinued and have not stopped at least 7 days prior to randomization.
- •Concomitant therapy with eplerenone, spironolactone, canrenone, esaxerenone, or any other mineralocorticoid receptor agonist, sacubitril/valsartan combination, or potassium-sparing diuretic which cannot be discontinued at least 8 weeks prior to the Screening visit.
- •Patients can be treated with SGLT2 inhibitors, but the type and dose should be stable for at least 4 weeks prior to screening.
- •Participants treated with immunosuppressive therapy, including corticosteroids other than topical or inhaled, within the last 24 weeks.
- •Previous assignment to study intervention during this study.
- •Simultaneous participation in another interventional clinical study (e.g. Phase 1 to 3 clinical studies) or treatment with any investigational medicinal product within 8 weeks prior to randomization.
- •Participants known for lack of compliance with clinic visits or prescribed medication.
- •Participants with acute kidney injury requiring dialysis within 24 weeks prior to the Screening visit.
- •Known current alcohol and / or illicit drug abuse that may interfere with the participant’s safety and / or compliance at the discretion of the investigator.
- •Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site).
- •Participants with an HbA1c>11%.
- •Participants with type 1 diabetes.
- •Known hypersensitivity to the study intervention (active substance or excipients).
- •Participants with hepatic insufficiency classified as Child-Pugh C.
- •Participants with mean BP higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit.
- •Participants hospitalized due to a CV event within 4 weeks prior to Screening visit (heart failure decompensation, acute coronary syndrome, stroke, transient ischemic attack, acute limb ischemia).
- •Symptomatic heart failure with reduced ejection fraction with class 1A indication for MRAs.
结局指标
主要结局
Change in UACR from baseline (ratio to baseline) over 6 months
Change in UACR from baseline (ratio to baseline) over 6 months
次要结局
- Number of participants with TEAEs, TESAEs
- Number of participants with Hyperkalemia (AESI)
研究者
Hiddo Lambers-Heerspink
Scientific
Universitair Medisch Centrum Groningen
研究点 (11)
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