Optimization of Albuminuria Lowering Therapies to Individual Patients With CKD Using FINErenone and SEmaglutide
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Proportion of patients with ≥30% reduction in urinary albumin:creatinine ratio (UACR) from baseline during monotherapy with finerenone or semaglutide or combined treatment with finerenone-semaglutide.
研究概览
简要总结
The FINESSE-CKD trial investigates a personalized approach to the treatment of chronic kidney disease (CKD) by comparing the effects of finerenone and semaglutide on albuminuria. Approximately 36 participants will receive both treatments in a randomized crossover design, with the aim of identifying which treatment provides the greatest individual reduction in albuminuria. The primary objective is to determine whether a reduction of at least 30% in albuminuria can be achieved. The study will also assess the effect of combining both treatments and the feasibility of remotely monitoring treatment response through home measurements and urine collections. The total study duration is approximately 40 weeks.
详细描述
The FINESSE-CKD trial investigates whether treatment for chronic kidney disease (CKD) can be personalized based on an individual patient's response to finerenone and semaglutide. Although both treatments have been shown to reduce albuminuria and improve kidney and cardiovascular outcomes in relevant patient populations, treatment response can vary considerably between individuals. The study therefore aims to identify whether selecting the treatment that provides the greatest reduction in albuminuria for each individual patient can achieve a clinically relevant reduction of at least 30% in urinary albumin-to-creatinine ratio (UACR).
This is a randomized, open-label, crossover, multicenter, decentralized clinical trial. Participants will receive finerenone and semaglutide according to the study treatment schedule, allowing the response to each treatment to be assessed within the same individual. The study will also evaluate whether combined treatment with finerenone and semaglutide provides additional albuminuria lowering compared with the individually selected treatment.
A decentralized approach will be used to reduce the need for hospital visits and assess the feasibility of monitoring treatment response remotely. Participants will perform selected measurements and urine collections at home, including monitoring of body weight and blood pressure.
The primary outcome is the proportion of participants achieving a ≥30% reduction in UACR. Secondary outcomes include the percentage change in UACR from baseline and the feasibility of remote urine collection. The study is expected to provide insight into whether an individualized treatment strategy can improve the effectiveness of albuminuria-lowering therapy while reducing unnecessary treatment and patient burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Urinary albumin to creatinine ratio ≥100 mg/g and ≤3500 mg/g
- •eGFR ≥25 and ≤90 mL/min/1.73m2
- •HbA1c ≥5.7 and ≤11%
- •On a stable dose of an ACEi/ARB for at least 4 weeks if tolerated
- •On a stable dose of a SGLT2 inhibitor for at least 4 weeks if tolerated
- •Willing to sign an informed consent
排除标准
- •Diagnosis of type 1 diabetes
- •Heart Failure with reduced ejection fraction and NYHA Class II to IV
- •Acute coronary syndrome event within 6 months
- •Serum potassium > 5.0 mmol/L
- •Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt;
- •Active pregnancy or breastfeeding
- •History of kidney or liver transplant
- •Active malignancy
- •Suggestive evidence of adrenal insufficiency
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
- •Personal history of non-familial medullary thyroid carcinoma
- •History of severe hypersensitivity or contraindications to any MRA or GLP-1 RA
- •Uncontrolled arterial hypertension (mean sitting systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg)
- •Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- •History of active inflammatory bowel disease within the 6 months;
- •Major gastrointestinal tract surgery as determined by the physician;
- •Pancreatitis within 6 months.
- •GI ulcers and/or bleeding within 6 months;
- •Evidence of urinary obstruction or difficulty in voiding at screening.
- •Use of any of the following medications: CYP3A4 inhibitors, potassium sparing medications, trimethoprim, trimethoprim/sulfamethoxazole, GLP-1 RAs, and potassium supplements.
- •Participation in any clinical trial within 3 months prior to initial dosing.
- •Donation or loss of ≧400 ml blood within 8 weeks prior to initial dosing.
- •History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or according to investigator's assessment.
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •Women of childbearing potential (WOCBP):15
- •WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized.
- •WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening.
- •Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent)
研究组 & 干预措施
Finerenone (monotherapy) first
6 weeks finerenone monotherapy → 6-week wash-out → 12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out.
干预措施: Finerenone (BAY 94-8862) (Drug)
Finerenone (monotherapy) first
6 weeks finerenone monotherapy → 6-week wash-out → 12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out.
干预措施: Semaglutide 14 MG [Rybelsus] (Drug)
Finerenone (monotherapy) first
6 weeks finerenone monotherapy → 6-week wash-out → 12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out.
干预措施: Finerenone and Semaglutide (Drug)
Semaglutide (monotherapy) first
12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out → 6 weeks finerenone monotherapy → 6-week wash-out.
干预措施: Finerenone (BAY 94-8862) (Drug)
Semaglutide (monotherapy) first
12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out → 6 weeks finerenone monotherapy → 6-week wash-out.
干预措施: Semaglutide 14 MG [Rybelsus] (Drug)
Semaglutide (monotherapy) first
12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out → 6 weeks finerenone monotherapy → 6-week wash-out.
干预措施: Finerenone and Semaglutide (Drug)
结局指标
主要结局
Proportion of patients with ≥30% reduction in urinary albumin:creatinine ratio (UACR) from baseline during monotherapy with finerenone or semaglutide or combined treatment with finerenone-semaglutide.
时间窗: From baseline to the end of study (Week 37)
次要结局
- Number of missed urine collection in the remote (@home) setting(From baseline to end of study (Week 37))
- Percentage change in UACR(From baseline to end of study (week 37))