jRCT2031210597招募中不适用
Randomised, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with diabetic and non-diabetic chronic kidney disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 552
- 主要终点
- Change from treatment period baseline in log transformed Urine Albumin Creatinine Ratio (UACR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- •Male or female patients of legal adult age (according to local legislation) and aged >= 18 years at time of consent.
- •estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI) formula] >= 30 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis.
- •Urine Albumin Creatinine Ratio (UACR) >= 200 and < 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit
- •If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone <=10 mg or equivalent).
- •Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for >= 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial.
- •In the Investigator's opinion, one or more of the following underlying kidney disease causes:
- •#Diabetic kidney disease. These patients must have type 2 diabetes mellitus and their treatment (including Glucagon-Like Peptide-1 (GLP1) receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation.
- •#Hypertensive kidney disease
- •#Chronic glomerulonephritis defined as one of the following: Immunoglobulin A (IgA) nephropathy, Membranous nephropathy, Focal Segmental Glomerulosclerosis (FSGS)
- •Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.
- •Serum potassium <= 4.8 mmol/L at Visit 1 measured by the central laboratory.
- •Seated Systolic Blood Pressure (SBP) >= 110 and <= 160 mmHg and Diastolic Blood Pressure (DBP) >= 65 and <= 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement.
- •Body Mass Index (BMI) >= 18.5 and < 50 kg/m2 at Visit
- •Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP.
- •Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period):
- •Serum potassium <= 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
- •eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) >= 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
排除标准
- •Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase.
- •Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded.
- •Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA))
- •Patients at increased risk of ketoacidosis in the opinion of the investigator.
- •Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.
- •Further criteria apply.
结局指标
主要结局
Change from treatment period baseline in log transformed Urine Albumin Creatinine Ratio (UACR)
时间窗: up to 14 weeks
Measured in First Morning Void urine
次要结局
- UACR response I(up to 14 weeks)
- UACR response II(up to 14 weeks)
研究者
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