EUCTR2021-003037-11-ES进行中（未招募）1 期
A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes. - CONFIDENCE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 807
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participant with a clinical diagnosis of chronic kidney disease (CKD)
- •and the following:
- •a. In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.
- •b. In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD.
- •c. 300 =UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening.
- •2. Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
- •3. Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.
- •Please refer to the protocol for a full list of inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 207
排除标准
- •1. Participants with type 1 diabetes (T1D).
- •2. Participant with hepatic insufficiency classified as Child-Pugh C.
- •3. Participant with blood pressure at Day 1 visit higher than 160/100 or systolic blood pressure lower than 90 mmHg.
- •4. Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
- •5. Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
- •6. Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
- •7. Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening.
- •Please refer to the protocol for a full list of exclusion criteria
研究者
相似试验
招募中
1 期
A Phase 2 study to evaluate the efficacy and safety of SAR444656 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa.CTIS2023-504328-25-00Sanofi-Aventis Recherche & Developpement158
进行中（未招募）
1 期
A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alonein adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetesChronic kidney disease in type 2 diabetes mellitusMedDRA version: 21.1Level: LLTClassification code 10045250Term: Type II diabetes mellitus with renal manifestationsSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2021-003037-11-DKBayer AG807
招募中
2 期
Combination of finerenone and empagliflozin in participants with Kidney disease and Type 2DiabetesCTRI/2023/09/057826Fortrea Development India Private Limited
已完成
2 期
A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alone in adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetes.2023-506981-30-00Bayer AG220
招募中
2 期
Combination of finerenone and empagliflozin in participants with CKD and T2DChronic Kidney Disease and Type 2 DiabetesJPRN-jRCT2071220067Myoishi Masafumi807